TMS for Adults With Autism and Depression (TAD)
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|ClinicalTrials.gov Identifier: NCT02939560|
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Depression Depressive Disorder Major Depressive Disorder||Device: NeuroStar® TMS device (Neuronetics, Atlanta, GA)||Not Applicable|
Aim 1. Determine the safety and therapeutic efficacy of left-sided DLPFC high frequency rTMS on MDD symptoms in patients with ASD: The investigators hypothesize that patients receiving the rTMS will tolerate the treatment course without difficulty and have clinically significant reduction of depressive symptoms after receiving all 25 sessions, as compared with their symptom burden prior to initiating TMS. Depression symptom data will be collected as pre- and post-TMS scores on Hamilton Depression Rating Scale (HAM-D). Depression scores will also be monitored periodically during course of TMS with Patient Health Questionnaires (PHQ-9).
Exploratory sub-aim - Monitoring for durability of response: The investigators hypothesize that subjects receiving rTMS will demonstrate durability of response in their depression symptom reduction, as measured by HAM-D scores at 1 month and 3 months post-TMS.
Aim 2. Determine the effect of left DLPFC rTMS on core symptoms of ASD: The investigators hypothesize that subjects will experience reduction in core symptoms of ASD after completing all 25 sessions, as compared with their symptom burden prior to initiating treatment. For social and communication deficits, informant and/or self-report evaluations will be made pre- and post-TMS with the Social Responsiveness Scale (SRS), the Ritvo Autism Aspergers Diagnostic Scale-Revised (RAADS-R) and the Aberrant Behavior Checklist (ABC). Repetitive and restricted behavior will be evaluated using the Repetitive Behavior Scale-Revised (RBS-R), the ABC, and RAADS.
Exploratory sub-aim: Determine if there are changes to functional brain connectivity during face and object processing tasks via functional MRI imaging in patients with Autism who receive rTMS: The study investigators hypothesize that there will be altered brain connectivity evident in patients' baseline fMRI during cognitive processing tasks prior to TMS reflected as both hyper- and hypo-connectivity, and that there will be some level of normalization of these patterns in fMRI after completion of TMS series, particularly in the prefrontal cortex.
Exploratory sub-aim - Monitoring for durability of response: The study investigators hypothesize that subjects receiving rTMS will exhibit durability of response in their ASD symptom reduction, as measured by ABC, SRS, RAADS, AND RBR scores at 1 month and 3 months post-TMS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transcranial Magnetic Stimulation for Adults With Autism Spectrum Disorder and Depression|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||September 20, 2018|
Participants will receive rTMS sessions according to the study protocol.
Device: NeuroStar® TMS device (Neuronetics, Atlanta, GA)
Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
- Change from Baseline in Depressive Symptoms [ Time Frame: Baseline, Week 5, Week 9, Week 17 ]Hamilton Rating Scale for Depression Scale
- Change from Baseline in Depressive Symptoms [ Time Frame: Baseline and twice weekly during weeks 1 through 5 ]Patient Health Questionnaire
- Change from Baseline in Autism Spectrum Disorder Symptoms [ Time Frame: Baseline, Week 5, Week 9, Week 17 ]Aberrant Behavior Checklist
- Change from Baseline in Autism Spectrum Disorder Symptoms [ Time Frame: Baseline, Week 5, Week 9, Week 17 ]Social Responsiveness Scale-2
- Change from Baseline in Autism Spectrum Disorder Symptoms [ Time Frame: Baseline, Week 5, Week 9, Week 17 ]Ritvo Autism-Aspergers Diagnostic Scale
- Change from Baseline in Autism Spectrum Disorder Symptoms [ Time Frame: Baseline, Week 5, Week 9, Week 17 ]Repetitive Behavior Scale-Revised
- Change from Baseline in Autism Spectrum Disorder Symptoms [ Time Frame: Baseline, Week 5 ]Functional MRI scanning during cognitive processing tasks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939560
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|