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Trial record 12 of 24 for:    Developmental Disabilities | ( Map: South Carolina, United States )

TMS for Adults With Autism and Depression (TAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02939560
Recruitment Status : Completed
First Posted : October 20, 2016
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE September 29, 2016
First Posted Date  ICMJE October 20, 2016
Results First Submitted Date  ICMJE June 24, 2019
Results First Posted Date  ICMJE October 1, 2019
Last Update Posted Date October 1, 2019
Study Start Date  ICMJE September 2016
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • 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 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 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • 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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
Change From Baseline in Functional MRI Scanning During Cognitive Processing Tasks [ Time Frame: Baseline, Week 5 ]
Functional MRI data during cognitive processing tasks
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TMS for Adults With Autism and Depression
Official Title  ICMJE Transcranial Magnetic Stimulation for Adults With Autism Spectrum Disorder and Depression
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorder
  • Depression
  • Depressive Disorder
  • Major Depressive Disorder
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: rTMS
Participants will receive rTMS sessions according to the study protocol.
Intervention: Device: NeuroStar® TMS device (Neuronetics, Atlanta, GA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2018)
13
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
15
Actual Study Completion Date  ICMJE September 20, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
    • 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
    • are currently enrolled in a course in which the PI or co-I's are instructors
    • cannot understand the task instructions
    • cannot lay still in the mock scanner for a period of 6 minutes
  • Inability or unwillingness of participant or legal guardian/representative to give informed consent
  • There will be no discrimination or exclusions based on race, gender, sexual orientation, or other socioeconomic factors. Of note, while both male and female participants will be actively and equally recruited using the same methods. The natural distribution of autism in the population skews towards significant towards male gender, with male prevalence being 4-5 times that of female prevalence. Our study will therefore likely have more male participants than female due to this trend in prevalence.
  • Children (age <18) are being excluded from this study for several reasons. While autism is a pediatric neurodevelopmental disorder with symptom onset as young as one year of age, it is also one that is chronic throughout adulthood. Both children with autism and neurotypical children undergo periods of rapid change in brain size, structure, and organization as they age, and the interaction between a full rTMS series and brains that are still involved in periods of very active development and whom may also be at different points along their own developmental timelines may skew or alter the data that is collected. Additionally, due to both brain growth and increases in skull thickness, children of different ages may have significantly different "scalp to cortex" distances, which can result in very different patterns of cortical stimulation despite uniform coil positioning. This will be an added, unnecessary variable which would compromise the attempt at performing a standardized protocol. Finally, while high frequency rTMS is an FDA approved treatment for depression in adults, it has not yet been FDA approved in children and adolescents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939560
Other Study ID Numbers  ICMJE Pro00056546
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP