rTMS for Executive Function Deficits in Autism Spectrum Disorder

March 5, 2019 updated by: Stephanie Ameis, Centre for Addiction and Mental Health

Repetitive Transcranial Magnetic Stimulation (rTMS) for Executive Function Deficits in Autism Spectrum Disorder and Effects on Brain Structure: A Pilot Study

In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) on executive function deficits in individuals with autism spectrum disorder. Half of the participants will be chosen by chance to receive active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel the same as active rTMS only there will be no direct brain stimulation. This is necessary to ensure that active rTMS is efficacious in the enhancement of executive function in individuals with autism spectrum disorder. Based on results from a recently published pilot study, the investigators propose that active rTMS treatment will result in a significant improvement in working memory performance compared to sham rTMS treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) as a treatment for executive function deficits in individuals with autism spectrum disorder between 16 and 25 years of age. The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times a week, for about 1 hour each. Several scales will be used to assess for symptom severity and adaptive functioning. Cognition will be assessed using a validated battery.

This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of rTMS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow while participants are completing some basic tasks to asses brain function.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addictions and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria Autism Spectrum Disorder (ASD):

  • Are fluent in the English language
  • Have a diagnosis of high functioning ASD (HF-ASD) (i.e., are verbal with an Intelligence Quotient (IQ) ≥ 70)
  • Are competent to consent based on the subjects' ability to provide a spontaneous narrative description of the key elements of the study
  • Are clinically stable as determined by their treating physician, with no medication changes over the past 4 weeks

Exclusion Criteria (ASD):

  • Have a history of substance abuse or dependence in the last 6 months or have a positive urine toxicology screen
  • Have a concomitant major medical or neurologic illness
  • Have had a seizure in the past, or have a first-degree relative with epilepsy
  • Have an abnormal clinical EEG
  • Are pregnant or likely to get pregnant during the next 4 weeks
  • Are clinically unstable
  • Are on benzodiazepines or anticonvulsant medication
  • Have a history of rTMS treatment.

Inclusion Criteria (Healthy Controls):

  • Are fluent in the English language
  • Competent to consent

Exclusion Criteria (Healthy Controls):

  • Have a history of substance abuse or dependence in the last 6 months or have a positive urine toxicology screen
  • Have a major medical or neurologic illness
  • Have a diagnosed learning disorder or impaired academic or adaptive functioning on history
  • Are pregnant
  • Have an IQ < 80
  • Have a psychiatric diagnosis on diagnostic interview assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active rTMS

Active treatment will be delivered at an intensity that is 90% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 25 simulation trains of 30 stimuli each (i.e., 750 stimuli) and an intertrain interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right dorsolateral prefrontal cortex (DLPFC). The order of bilateral stimulation (i.e. right then left or left than right) will be held constant for all 20 treatments.

Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Device: Repetitive Transcranial Magnetic Stimulation
rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
Other Names:
  • MagPro x100 series (Medtronic A/S, Copenhagen, Denmark)
Sham Comparator: Sham rTMS

Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees way from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g. contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.

Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Device: Repetitive Transcranial Magnetic Stimulation
rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
Other Names:
  • MagPro x100 series (Medtronic A/S, Copenhagen, Denmark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in accuracy on the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Task
Time Frame: Baseline; Post rTMS (4 weeks after baseline); One month follow up ( 4 weeks after post rTMS); 6 month follow up (post rTMS); One year follow up (post rTMS)
Specifically the investigators will evaluate the changes in spatial working memory scores before and after rTMS treatment.
Baseline; Post rTMS (4 weeks after baseline); One month follow up ( 4 weeks after post rTMS); 6 month follow up (post rTMS); One year follow up (post rTMS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in scores on Behaviour Rating Inventory of Executive Functioning (A) (BRIEF) (A)
Time Frame: Baseline; Post rTMS (4 weeks after baseline); One month follow up ( 4 weeks after post rTMS); 6 month follow up (post rTMS); One year follow up (post rTMS)
Specifically the investigators will evaluate the changes in executive function (EF) scores before and after rTMS treatment.
Baseline; Post rTMS (4 weeks after baseline); One month follow up ( 4 weeks after post rTMS); 6 month follow up (post rTMS); One year follow up (post rTMS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Academic Health Science Centres

Investigators

  • Principal Investigator: Stephanie H Ameis, M.D., M.S.C, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

May 4, 2018

Study Completion (Actual)

May 4, 2018

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 119/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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