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rTMS for Executive Function Deficits in Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT02311751
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Academic Health Science Centres
Information provided by (Responsible Party):
Stephanie Ameis, Centre for Addiction and Mental Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Repetitive Transcranial Magnetic Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) for Executive Function Deficits in Autism Spectrum Disorder and Effects on Brain Structure: A Pilot Study
Actual Study Start Date : October 2014
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: MagPro x100 series (Medtronic A/S, Copenhagen, Denmark)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311751


Locations
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Canada, Ontario
Centre for Addictions and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
Academic Health Science Centres
Investigators
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Principal Investigator: Stephanie H Ameis, M.D., M.S.C Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: Stephanie Ameis, Clinician Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02311751     History of Changes
Other Study ID Numbers: 119/2013
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stephanie Ameis, Centre for Addiction and Mental Health:
Autism Spectrum Disorder
Executive Function
rTMS (Repetitive Transcranial Magnetic Stimulation)
MRI (Magnetic Resonance Imaging)
Healthy Subjects

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders