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Completed

NCT Number: NCT02311751

rTMS for Executive Function Deficits in Autism Spectrum Disorder

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.

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Key information

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addictions and Mental Health

Toronto, Ontario, M6J 1H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Academic Health Science Centres

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2014
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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