Transcranial Magnetic Stimulation for Adults With Autism Spectrum Disorder and Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Medical University of South Carolina
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Aberrant Behavior Checklist
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Autism Spectrum Disorder and active depressive symptoms.
Exclusion Criteria
- •List specific contraindicationsUncontrolled and/or untreated seizure disorder as defined by any incidence of seizure within the past 6 months. Patients with diagnosed epilepsy, or prior seizures, will be allowed in the study if they are taking an anticonvulsant medication, or have not had a seizure in the past year off medications.
- •Moderate to severe intellectual disability (ID) as defined by IQ \< 60, determined by prior IQ testing or Wechsler Abbreviated Scale of Intelligence (WASC-II) if no prior test results available
- •Other psychiatric or neurodevelopmental illness that is the primary area of clinical focus (including but not limited to primary psychotic disorder, substance abuse disorder, and ASD or ID which are secondary to genetic syndromes)
- •Active suicidal ideation or suicide attempt in the 90 days prior to initial assessment
- •Presence of any metal implants or devices in the head or neck (e.g. metal plates or screws)
- •No participants who are pregnant or who are planning to become pregnant
- •Exclusion criteria for fMRI scanning:
- •have metal pins, plates or clips in the body or have orthodontics
- •have surgical implants such as pacemakers or cochlear implants
- •have permanent makeup or tattoos near the face or head
Outcomes
Primary Outcomes
Change From Baseline in Aberrant Behavior Checklist
Time Frame: Baseline, Week 5, Week 9, Week 17
Aberrant Behavior Checklist. Minimum 0, maximum 174. Higher scores indicate worse behaviors.
Change From Baseline in Social Responsiveness Scale-2
Time Frame: Baseline, Week 5, Week 9, Week 17
Social Responsiveness Scale-2. Minimum 0, maximum 195. Higher indicates worse behaviors
Change From Baseline in Hamilton Depression Rating Scale
Time Frame: Baseline through Week 5
Hamilton Depression Rating Scale (HAM-D) with 17 questions. Minimum score = 0, maximum 53. Higher scores mean more severe depression.
Change From Baseline in Ritvo Autism-Aspergers Diagnostic Scale
Time Frame: Baseline, Week 5, Week 9, Week 17
Ritvo Autism-Aspergers Diagnostic Scale. Minimum 0, maximum 240. Higher indicates worse symptoms.
Change From Baseline in Repetitive Behavior Scale-Revised
Time Frame: Baseline, Week 5, Week 9, Week 17
Repetitive Behavior Scale-Revised Global Impression. Minimum 0, maximum 100. Higher indicates worse behaviors
Secondary Outcomes
- Change From Baseline in Functional MRI Scanning During Cognitive Processing Tasks(Baseline, Week 5)