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JAMA Psychiatry Feb 2020This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms. (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms.
OBJECTIVE
To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks.
DESIGN, SETTING, AND PARTICIPANTS
This multisite, blinded, sham-procedure, randomized clinical trial used a 2:1 SGB:sham ratio and was conducted from May 2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers. Only physicians performing the procedures and the procedure nurses were aware of the intervention (but not the participants or assessors); their interactions with the participants were scripted and limited to the 2 interventions. Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist-Civilian Version (PCL-C) score of 32 or more at screening were included. Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months.
INTERVENTIONS
Paired right-sided SGB or sham procedures at weeks 0 and 2.
MAIN OUTCOMES AND MEASURES
Improvement of 10 or more points on mean CAPS-5 total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline total symptom severity scores (planned a priori).
RESULTS
Of 190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study. Baseline characteristics were similar in the SGB and sham treatment groups, with mean (SD) CAPS-5 scores of 37.6 (11.2) and 39.8 (14.4), respectively (on a scale of 0-80); 91 (80.0%) met CAPS-5 PTSD criteria. In an intent-to-treat analysis, adjusted mean total symptom severity score change was -12.6 points (95% CI, -15.5 to -9.7 points) for the group receiving SGB treatments, compared with -6.1 points (95% CI, -9.8 to -2.3 points) for those receiving sham treatment (P = .01).
CONCLUSIONS AND RELEVANCE
In this trial of active-duty service members with PTSD symptoms (at a clinical threshold and subthreshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores over 8 weeks. The mild-moderate baseline level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB merits further trials as a PTSD treatment adjunct.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03077919.
Topics: Anesthetics, Local; Animals; Autonomic Nerve Block; Double-Blind Method; Female; Humans; Injections; Male; Psychiatric Status Rating Scales; Ropivacaine; Stellate Ganglion; Stress Disorders, Post-Traumatic
PubMed: 31693083
DOI: 10.1001/jamapsychiatry.2019.3474 -
Circulation Research Dec 2010coronary artery ligation to induce myocardial infarction (MI) in mice is typically performed by an invasive and time-consuming approach that requires ventilation and...
RATIONALE
coronary artery ligation to induce myocardial infarction (MI) in mice is typically performed by an invasive and time-consuming approach that requires ventilation and chest opening (classic method), often resulting in extensive tissue damage and high mortality. We developed a novel and rapid surgical method to induce MI that does not require ventilation.
OBJECTIVE
the purpose of this study was to develop and comprehensively describe this method and directly compare it to the classic method.
METHODS AND RESULTS
male C57/B6 mice were grouped into 4 groups: new method MI (MI-N) or sham (S-N) and classic method MI (MI-C) or sham (S-C). In the new method, heart was manually exposed without intubation through a small incision and MI was induced. In the classic method, MI was induced through a ventilated thoracotomy. Similar groups were used in an ischemia/reperfusion injury model. This novel MI procedure is rapid, with an average procedure time of 1.22 ± 0.05 minutes, whereas the classic method requires 23.2 ± 0.6 minutes per procedure. Surgical mortality was 3% in MI-N and 15.9% in MI-C. The rate of arrhythmia was significantly lower in MI-N. The postsurgical levels of tumor necrosis factor-α and myeloperoxidase were lower in new method, indicating less inflammation. Overall, 28-day post-MI survival rate was 68% with MI-N and 48% with MI-C. Importantly, there was no difference in infarct size or post-MI cardiac function between the methods.
CONCLUSIONS
this new rapid method of MI in mice represents a more efficient and less damaging model of myocardial ischemic injury compared with the classic method.
Topics: Animals; Coronary Vessels; Disease Models, Animal; Ligation; Male; Methods; Mice; Mice, Inbred C57BL; Myocardial Infarction; Research Design; Time Factors
PubMed: 20966393
DOI: 10.1161/CIRCRESAHA.110.223925 -
International Journal of Environmental... Aug 2022The aim of this study was to assess the effectiveness of microcurrent therapy for healing pressure ulcers in aged people. A multicentric, randomized clinical trial was... (Randomized Controlled Trial)
Randomized Controlled Trial
The aim of this study was to assess the effectiveness of microcurrent therapy for healing pressure ulcers in aged people. A multicentric, randomized clinical trial was designed with a sham stimulation control. The experimental group received an intervention following a standardized protocol for curing ulcers combined with 10 h of microcurrent therapy daily for 25 days. The sham group received the same curing protocol plus a sham microcurrent stimulation. The studied healing-related variables were the Pressure Ulcer Scale for Healing (PUSH) and the surface, depth, grade, and number of ulcers that healed completely. Three evaluations were conducted: pre-intervention (T1), 14 days following the start of the intervention (T2), and 1 day after the intervention was completed (T3). In total, 30 participants met the inclusion criteria ( = 15 in each group). The improvement in the PUSH at T2 and T3 was 16.8% (CI95% 0.5-33.1) and 25.3% (CI95% 7.6-43.0) greater in the experimental group versus the sham control, respectively. The reduction in the wound area at T2 and T3 was 20.1% (CI95% 5.2-35.0) and 28.6% (CI95% 11.9-45.3) greater in the experimental group versus the control, respectively. Microcurrent therapy improves the healing of pressure ulcers in older adults, both quantitatively and qualitatively.
Topics: Aged; Double-Blind Method; Humans; Pressure Ulcer; Ulcer; Varicose Ulcer; Wound Healing
PubMed: 36011679
DOI: 10.3390/ijerph191610045 -
JAMA Neurology Dec 2018Aphasia is a debilitating language disorder for which behavioral speech therapy is the most efficient treatment, but therapy outcomes are variable and full recovery is... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Aphasia is a debilitating language disorder for which behavioral speech therapy is the most efficient treatment, but therapy outcomes are variable and full recovery is not always achieved. It remains unclear if adjunctive brain stimulation (anodal transcranial direct current stimulation [A-tDCS]) applied during aphasia therapy can improve outcomes.
OBJECTIVE
To examine the futility of studying A-tDCS as an adjunctive intervention during speech therapy to improve speech production (naming) for individuals with long-term poststroke aphasia.
DESIGN, SETTING, AND PARTICIPANTS
Double-blinded, prospective randomized clinical trial using a futility design to test adjunctive A-tDCS during speech therapy. The setting was an outpatient clinic. Enrollment of individuals began in August 2012 and was completed in March 2017, and the duration of follow-up was 6 months. Analyses began in April 2017. The study recruited from a volunteer sample, and 89 patients were screened. Patients with long-term (>6 months) aphasia due to 1 previous left hemisphere stroke were enrolled. In comparing A-tDCS and sham tDCS, patients were matched based on site (University of South Carolina or Medical University of South Carolina), baseline age, type of aphasia, and aphasia severity.
INTERVENTIONS
Outpatient speech therapy for 3 weeks (15 sessions, 45 minutes each) combined with either A-tDCS vs sham tDCS applied to preserved left temporal lobe regions.
MAIN OUTCOMES AND MEASURES
The primary outcome was the ability to name common objects, assessed twice before and after therapy.
RESULTS
A total of 74 patients were enrolled. Participants had a mean (SD) age of 60 (10) years, had 15 (2) years of education, and were 44 (40) months from stroke onset. There were 52 men (70%) and 62 non-Hispanic white individuals (84%). Most were retired or not employed (59 [80%]). Broca aphasia was the most common aphasia type (39 [52.7%]). The adjusted mean (SE) change from pretreatment baseline in correct naming was 13.9 (2.4) words (95% CI, 9.0-18.7) for A-tDCS and 8.2 (2.2) words (95% CI, 3.8-12.6) for sham tDCS, with mean (SE) A-tDCS difference of 5.7 (3.3) words (95% CI, -0.9 to 12.3), indicating a relative 70% increase in correct naming for A-tDCS relative to sham. The futility hypothesis P value was .90, indicating failure to reject the null hypothesis and, therefore, providing no evidence that further study of A-tDCS is futile. No serious adverse events were associated with A-tDCS.
CONCLUSIONS AND RELEVANCE
Our findings provide motivation to proceed with another trial to study the effect of A-tDCS on the outcome of aphasia treatment in individuals poststroke. Anodal tDCS during speech therapy is feasible and potentially transformative for aphasia treatment and should be further studied.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01686373.
Topics: Aged; Aphasia; Aphasia, Broca; Combined Modality Therapy; Double-Blind Method; Female; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Placebos; Research Design; Speech Therapy; Stroke; Temporal Lobe; Transcranial Direct Current Stimulation
PubMed: 30128538
DOI: 10.1001/jamaneurol.2018.2287 -
Journal of Oral Rehabilitation Apr 2020Dysphagia following stroke is prevalent; however, dysphagia treatment is often applied haphazardly and outcomes unclear. Neuromuscular electrical stimulation (NMES) has... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Dysphagia following stroke is prevalent; however, dysphagia treatment is often applied haphazardly and outcomes unclear. Neuromuscular electrical stimulation (NMES) has received increased attention as a treatment for post-stroke dysphagia; but application data remain conflicted.
OBJECTIVE
This study investigated effectiveness and safety of an exercise-based swallowing therapy (McNeill Dysphagia Therapy: MDTP) +NMES for dysphagia rehabilitation following stroke.
METHODS
Stroke patients (n = 53, x̅ age: 66 [13.2], 47.2% male) with dysphagia admitted to sub-acute rehabilitation hospital were randomised to MDTP + NMES [NMES], MDTP + sham NMES [MDTP] or usual care [UC] swallowing therapy groups. Patients were treated for 1 hour per day for 3 weeks and monitored to 3 months by a blinded evaluator. Outcomes included clinical swallowing ability, oral intake, weight, patient perception of swallow and occurrence of dysphagia-related complications.
RESULTS
Post-treatment dysphagia severity and treatment response were significantly different between groups (P ≤ .0001). MDTP demonstrated greater positive change than either NMES or UC arms, including increase in oral intake (χ = 5, P ≤ .022) and improved functional outcome by 3 months post-stroke (RR = 1.72, 1.04-2.84). Exploratory Cox regression revealed the MDTP group conferred the greatest benefit in time to "return to pre-stroke diet" of 4.317 [95% CI: 1.08- 17.2, P< .03].
CONCLUSION
Greater benefit (eg reduction in dysphagia severity, improved oral intake and earlier return to pre-stroke diet) resulted from a programme of MDTP alone vs NMES or UC.
Topics: Aged; Deglutition; Deglutition Disorders; Double-Blind Method; Electric Stimulation Therapy; Female; Humans; Male; Stroke; Stroke Rehabilitation; Treatment Outcome
PubMed: 31880338
DOI: 10.1111/joor.12928 -
The New England Journal of Medicine Aug 2016Uncontrolled pilot studies have suggested the efficacy of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance for the treatment of essential... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Uncontrolled pilot studies have suggested the efficacy of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance for the treatment of essential tremor.
METHODS
We enrolled patients with moderate-to-severe essential tremor that had not responded to at least two trials of medical therapy and randomly assigned them in a 3:1 ratio to undergo unilateral focused ultrasound thalamotomy or a sham procedure. The Clinical Rating Scale for Tremor and the Quality of Life in Essential Tremor Questionnaire were administered at baseline and at 1, 3, 6, and 12 months. Tremor assessments were videotaped and rated by an independent group of neurologists who were unaware of the treatment assignments. The primary outcome was the between-group difference in the change from baseline to 3 months in hand tremor, rated on a 32-point scale (with higher scores indicating more severe tremor). After 3 months, patients in the sham-procedure group could cross over to active treatment (the open-label extension cohort).
RESULTS
Seventy-six patients were included in the analysis. Hand-tremor scores improved more after focused ultrasound thalamotomy (from 18.1 points at baseline to 9.6 at 3 months) than after the sham procedure (from 16.0 to 15.8 points); the between-group difference in the mean change was 8.3 points (95% confidence interval [CI], 5.9 to 10.7; P<0.001). The improvement in the thalamotomy group was maintained at 12 months (change from baseline, 7.2 points; 95% CI, 6.1 to 8.3). Secondary outcome measures assessing disability and quality of life also improved with active treatment (the blinded thalamotomy cohort)as compared with the sham procedure (P<0.001 for both comparisons). Adverse events in the thalamotomy group included gait disturbance in 36% of patients and paresthesias or numbness in 38%; these adverse events persisted at 12 months in 9% and 14% of patients, respectively.
CONCLUSIONS
MRI-guided focused ultrasound thalamotomy reduced hand tremor in patients with essential tremor. Side effects included sensory and gait disturbances. (Funded by InSightec and others; ClinicalTrials.gov number, NCT01827904.).
Topics: Activities of Daily Living; Aged; Double-Blind Method; Essential Tremor; Female; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Postoperative Complications; Quality of Life; Thalamus; Ultrasonic Therapy; Ultrasonography, Interventional
PubMed: 27557301
DOI: 10.1056/NEJMoa1600159 -
The Cochrane Database of Systematic... Dec 2020Convergence insufficiency is a common binocular vision disorder in which the eyes have a strong tendency to drift outward (exophoria) with difficulty turning the eyes... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Convergence insufficiency is a common binocular vision disorder in which the eyes have a strong tendency to drift outward (exophoria) with difficulty turning the eyes inward when reading or doing close work.
OBJECTIVES
To assess the comparative effectiveness and relative ranking of non-surgical interventions for convergence insufficiency through a systematic review and network meta-analysis (NMA).
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, PubMed and three trials registers up to 20 September 2019.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) examining any form of non-surgical intervention versus placebo, no treatment, sham treatment, or other non-surgical interventions. Participants were children and adults with symptomatic convergence insufficiency.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodology. We performed NMAs separately for children and adults.
MAIN RESULTS
We included 12 trials (six in children and six in adults) with a total of 1289 participants. Trials evaluated seven interventions: 1) office-based vergence/accommodative therapy with home reinforcement; 2) home-based pencil/target push-ups; 3) home-based computer vergence/accommodative therapy; 4) office-based vergence/accommodative therapy alone; 5) placebo vergence/accommodative therapy or other placebo intervention; 6) prism reading glasses; and 7) placebo reading glasses. Six RCTs in the pediatric population randomized 968 participants. Of these, the Convergence Insufficiency Treatment Trial (CITT) Investigator Group completed four RCTs with 737 participants. All four CITT RCTs were rated at low risk of bias. Diagnostic criteria and outcome measures were identical or similar among these trials. The four CITT RCTs contributed data to the pediatric NMA, incorporating interventions 1, 2, 3 and 5. When treatment success was defined by a composite outcome requiring both clinical measures of convergence to be normal, and also show a pre-specified magnitude of improvement, we found high-certainty evidence that office-based vergence/accommodative therapy with home reinforcement increases the chance of a successful outcome, compared with home-based computer vergence/accommodative therapy (risk ratio (RR) 1.96, 95% confidence interval (CI) 1.32 to 2.94), home-based pencil/target push-ups (RR 2.86, 95% CI 1.82 to 4.35); and placebo (RR 3.04, 95% CI 2.32 to 3.98). However, there may be no evidence of any treatment difference between home-based computer vergence/accommodative therapy and home-based pencil/target push-ups (RR 1.44, 95% CI 0.93 to 2.24; low-certainty evidence), or between either of the two home-based therapies and placebo therapy, for the outcome of treatment success. When treatment success was defined as the composite convergence and symptom success outcome, we found moderate-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement were 5.12 (95% CI 2.01 to 13.07) times more likely to achieve treatment success than those who received placebo therapy. We found low-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement might be 4.41 (95% CI 1.26 to 15.38) times more likely to achieve treatment success than those who received home-based pencil push-ups, and 4.65 (95% CI 1.23 to 17.54) times more likely than those who received home-based computer vergence/accommodative therapy. There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy. One RCT evaluated the effectiveness of base-in prism reading glasses in children. When base-in prism reading glasses were compared with placebo reading glasses, investigators found no evidence of a difference in the three outcome measures of near point convergence (NPC), positive fusional vergence (PFV), or symptom scores measured by the Convergence Insufficiency Symptom Survey (CISS). Six RCTs in the adult population randomized 321 participants. We rated only one RCT at low risk of bias. Because not all studies of adults included composite success data, we could not conduct NMAs for treatment success. We thus were limited to comparing the mean difference (MD) between interventions for improving NPC, PFV, and CISS scores individually using data from three RCTs (107 participants; interventions 1, 2, 4 and 5). Compared with placebo treatment, office-based vergence accommodative therapy was relatively more effective in improving PFV (MD 16.73, 95% CI 6.96 to 26.60), but there was no evidence of a difference for NPC or the CISS score. There was no evidence of difference for any other comparisons for any outcomes. One trial evaluated base-in prism glasses prescribed for near-work activities and found that the prism glasses group had fewer symptoms compared with the placebo glasses group at three months (MD -8.9, 95% CI -11.6 to -6.3). The trial found no evidence of a difference with this intervention in NPC or PFV. No adverse effects related to study treatments were reported for any of the included studies. Excellent adherence was reported for office-based vergence/accommodative therapy (96.6% or higher) in two trials. Reported adherence with home-based therapy was less consistent, with one study reporting decreasing adherence over time (weeks 7 to 12) and lower completion rates with home-based pencil/target push-ups.
AUTHORS' CONCLUSIONS
Current research suggests that office-based vergence/accommodative therapy with home reinforcement is more effective than home-based pencil/target push-ups or home-based computer vergence/accommodative therapy for children. In adults, evidence of the effectiveness of various non-surgical interventions is less clear.
Topics: Adult; Bias; Child; Exotropia; Eyeglasses; Humans; Network Meta-Analysis; Ocular Motility Disorders; Orthoptics; Randomized Controlled Trials as Topic
PubMed: 33263359
DOI: 10.1002/14651858.CD006768.pub3 -
Neuropsychopharmacology : Official... Jan 2021Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for... (Randomized Controlled Trial)
Randomized Controlled Trial
Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for TRD in adolescents. This was the largest study to date examining the feasibility, safety, and efficacy of 10-Hz transcranial magnetic stimulation (TMS) for adolescents with TRD. Adolescents with TRD (aged 12-21 years) were enrolled in a randomized, sham-controlled trial of TMS across 13 sites. Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 [2.03]) and sham groups (-10.6 [2.00]; P = 0.8; difference [95% CI], - 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. Future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.
Topics: Adolescent; Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Double-Blind Method; Humans; Prefrontal Cortex; Transcranial Magnetic Stimulation; Treatment Outcome
PubMed: 32919400
DOI: 10.1038/s41386-020-00829-y -
JAMA Psychiatry Jun 2022Major depressive disorder (MDD) affects approximately 10% of the population globally. Approximately 20% to 30% of patients with MDD do not sufficiently respond to... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Major depressive disorder (MDD) affects approximately 10% of the population globally. Approximately 20% to 30% of patients with MDD do not sufficiently respond to standard treatment. Therefore, there is a need to develop more effective treatment strategies.
OBJECTIVE
To investigate whether the efficacy of cognitive behavioral therapy (CBT) for the treatment of MDD can be enhanced by concurrent transcranial direct current stimulation (tDCS).
DESIGN, SETTING, AND PARTICIPANTS
The double-blind, placebo-controlled randomized clinical trial PsychotherapyPlus was conducted at 6 university hospitals across Germany. Enrollment took place between June 2, 2016, and March 10, 2020; follow-up was completed August 27, 2020. Adults aged 20 to 65 years with a single or recurrent depressive episode were eligible. They were either not receiving medication or were receiving a stable regimen of antidepressant medication (selective serotonin reuptake inhibitor and/or mirtazapine). A total of 148 women and men underwent randomization: 53 individuals were assigned to CBT alone (group 0), 48 to CBT plus tDCS (group 1), and 47 to CBT plus sham-tDCS (group 2).
INTERVENTIONS
Participants attended a 6-week group intervention comprising 12 sessions of CBT. If assigned, tDCS was applied simultaneously. Active tDCS included stimulation with an intensity of 2 mA for 30 minutes (anode over F3, cathode over F4).
MAIN OUTCOMES AND MEASURES
The primary outcome was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to posttreatment in the intention-to-treat sample. Scores of 0 to 6 indicate no depression; 7 to 19, mild depression; 20 to 34, moderate depression; and 34 and higher, severe depression.
RESULTS
A total of 148 patients (89 women, 59 men; mean [SD] age, 41.1 [13.7] years; MADRS score at baseline, 23.0 [6.4]) were randomized. Of these, 126 patients (mean [SD] age, 41.5 [14.0] years; MADRS score at baseline, 23.0 [6.3]) completed the study. In each of the intervention groups, intervention was able to reduce MADRS scores by a mean of 6.5 points (95% CI, 3.82-9.14 points). The Cohen d value was -0.90 (95% CI, -1.43 to -0.50), indicating a significant effect over time. However, there was no significant effect of group and no significant interaction of group × time, indicating the estimated additive effects were not statistically significant. There were no severe adverse events throughout the whole trial, and there were no significant differences of self-reported adverse effects during and after stimulation between groups 1 and 2.
CONCLUSIONS AND RELEVANCE
Based on MADRS score changes, this trial did not indicate superior efficacy of tDCS-enhanced CBT compared with 2 CBT control conditions. The study confirmed that concurrent group CBT and tDCS is safe and feasible. However, additional research on mechanisms of neuromodulation to complement CBT and other behavioral interventions is needed.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02633449.
Topics: Adult; Cognitive Behavioral Therapy; Depression; Depressive Disorder, Major; Double-Blind Method; Female; Humans; Male; Transcranial Direct Current Stimulation; Treatment Outcome
PubMed: 35442431
DOI: 10.1001/jamapsychiatry.2022.0696 -
Brain Stimulation 2020In youth and young adults with autism spectrum disorder (ASD), executive function (EF) deficits may be a promising treatment target with potential impact on everyday... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In youth and young adults with autism spectrum disorder (ASD), executive function (EF) deficits may be a promising treatment target with potential impact on everyday functioning.
OBJECTIVE
To conduct a pilot randomized, double-blind, parallel, controlled trial evaluating repetitive transcranial magnetic stimulation (rTMS) for EF deficits in ASD.
METHOD
In Toronto, Ontario (November 2014 to June 2017), a 20-session, 4-week course of 20 Hz rTMS targeting dorsolateral prefrontal cortex (DLPFC) (90%RMT) was compared to sham stimulation in 16-35 year-olds with ASD (28 male/12 female), without intellectual disability, who had impaired everyday EF performance (n = 20 active/n = 20 sham). Outcome measures evaluated protocol feasibility and clinical effects of active vs. sham rTMS on EF performance. The moderating effect of baseline functioning was explored.
RESULTS
Of eligible participants, 95% were enrolled and 95% of randomized participants completed the protocol. Adverse events across treatment arms were mild-to-moderate. There was no significant difference between active vs. sham rTMS on EF performance. Baseline adaptive functioning moderated the effect of rTMS, such that participants with lower baseline functioning experienced significant EF improvement in the active vs. sham group.
CONCLUSIONS
Our pilot RCT demonstrated the feasibility and acceptability of using high frequency rTMS targeting DLPFC in youth and young adults with autism. No evidence for efficacy of active versus sham rTMS on EF performance was found. However, we found promising preliminary evidence of EF performance improvement following active versus sham rTMS in participants with ASD with more severe adaptive functioning deficits. Future work could focus on examining efficacy of rTMS in this higher-need population.
CLINICAL TRIAL REGISTRATION
Repetitive Transcranial Magnetic Stimulation (rTMS) for Executive Function Deficits in Autism Spectrum Disorder and Effects on Brain Structure: A Pilot Study; https://clinicaltrials.gov/ct2/show/NCT02311751?term = ameis&rank = 1; NCT02311751. The trial was funded by: an American Academy of Child and Adolescent Psychiatry (AACAP) Pilot Research Award, the Innovation Fund from the Alternate Funding Plan of the Academic Health Sciences Centres of Ontario, and an Ontario Mental Health Foundation (OMHF) Project A Grant and New Investigator Fellowship.
Topics: Adolescent; Autism Spectrum Disorder; Double-Blind Method; Executive Function; Female; Humans; Male; Middle Aged; Pilot Projects; Prefrontal Cortex; Transcranial Magnetic Stimulation
PubMed: 32289673
DOI: 10.1016/j.brs.2020.01.007