TMS for Adults With Autism and Depression

NCT02939560 | Completed Results DMC

• 1 other identifier: Pro00056546
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism Spectrum Disorder; Depression; Depressive Disorder; Major Depressive Disorder

Keywords

Autism Spectrum Disorder; Autism; Depressive; Depression

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Hamilton Depression Rating Scale

  Hamilton Depression Rating Scale (HAM-D) with 17 questions. Minimum score = 0, maximum 53. Higher scores mean more severe depression.

  Baseline through Week 5

• Change From Baseline in Aberrant Behavior Checklist

  Aberrant Behavior Checklist. Minimum 0, maximum 174. Higher scores indicate worse behaviors.

  Baseline, Week 5, Week 9, Week 17

• Change From Baseline in Social Responsiveness Scale-2

  Social Responsiveness Scale-2. Minimum 0, maximum 195. Higher indicates worse behaviors

  Baseline, Week 5, Week 9, Week 17

• Change From Baseline in Ritvo Autism-Aspergers Diagnostic Scale

  Ritvo Autism-Aspergers Diagnostic Scale. Minimum 0, maximum 240. Higher indicates worse symptoms.

  Baseline, Week 5, Week 9, Week 17

• Change From Baseline in Repetitive Behavior Scale-Revised

  Repetitive Behavior Scale-Revised Global Impression. Minimum 0, maximum 100. Higher indicates worse behaviors

  Baseline, Week 5, Week 9, Week 17

Secondary Outcomes (1)

• Change From Baseline in Functional MRI Scanning During Cognitive Processing Tasks

  Baseline, Week 5

Study Arms (1)

rTMS

EXPERIMENTAL

Participants will receive rTMS sessions according to the study protocol.

Device: NeuroStar® TMS device (Neuronetics, Atlanta, GA)

Interventions

NeuroStar® TMS device (Neuronetics, Atlanta, GA) DEVICE

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).

rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Autism Spectrum Disorder and active depressive symptoms.

You may not qualify if:

• 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
• 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
• have metal fragments in the body (from welding, shrapnel, BB guns) or suspect that they have fragments
• are claustrophobic
• are pregnant
• have ever suffered a closed head injury or concussion
• are currently under the influence of alcohol or other recreational drugs
• are a smoker

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (4)

• Perera T, George MS, Grammer G, Janicak PG, Pascual-Leone A, Wirecki TS. The Clinical TMS Society Consensus Review and Treatment Recommendations for TMS Therapy for Major Depressive Disorder. Brain Stimul. 2016 May-Jun;9(3):336-346. doi: 10.1016/j.brs.2016.03.010. Epub 2016 Mar 16.

  PMID: 27090022 BACKGROUND

• Oberman LM, Enticott PG, Casanova MF, Rotenberg A, Pascual-Leone A, McCracken JT; TMS in ASD Consensus Group. Transcranial magnetic stimulation in autism spectrum disorder: Challenges, promise, and roadmap for future research. Autism Res. 2016 Feb;9(2):184-203. doi: 10.1002/aur.1567. Epub 2015 Nov 4.

  PMID: 26536383 BACKGROUND

• George MS, Raman R, Benedek DM, Pelic CG, Grammer GG, Stokes KT, Schmidt M, Spiegel C, Dealmeida N, Beaver KL, Borckardt JJ, Sun X, Jain S, Stein MB. A two-site pilot randomized 3 day trial of high dose left prefrontal repetitive transcranial magnetic stimulation (rTMS) for suicidal inpatients. Brain Stimul. 2014 May-Jun;7(3):421-31. doi: 10.1016/j.brs.2014.03.006. Epub 2014 Mar 19.

  PMID: 24731434 RESULT

• Enticott PG, Fitzgibbon BM, Kennedy HA, Arnold SL, Elliot D, Peachey A, Zangen A, Fitzgerald PB. A double-blind, randomized trial of deep repetitive transcranial magnetic stimulation (rTMS) for autism spectrum disorder. Brain Stimul. 2014 Mar-Apr;7(2):206-11. doi: 10.1016/j.brs.2013.10.004. Epub 2013 Oct 27.

  PMID: 24280031 RESULT

Related Links

• Home page with information about the Primary Investigator

MeSH Terms

Conditions

Autism Spectrum Disorder; Depression; Depressive Disorder; Depressive Disorder, Major; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Mood Disorders

Results Point of Contact

• Title: McLeod F. Gwynette, MD
• Organization: Medical University of South Carolina

gwynette@musc.edu

843-792-9162

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 20, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 20, 2018
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)