TMS for Adults With Autism and Depression
Condition: Autism Spectrum Disorder; Depression; Depressive Disorder; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Autistic Disorder; Depressive Disorder, Major; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The goal of this proposal is to investigate whether a standard rTMS protocol for depression,
      including multiple sessions applied to left dorsolateral prefrontal cortex (DLPFC) results in
      reduction of depressive symptoms for adult patients with ASD and MDD (Aim 1). The secondary
      goal is to investigate and whether there is any beneficial reduction in the core symptoms of
      autism (Aim 2).
    

Detailed description: 
      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.
    

Intervention name(s): NeuroStar® TMS device (Neuronetics, Atlanta, GA)
Intervention type(s): Device
Intervention description(s): 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).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Autism; Depressive; Depression