NCT02311751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

3.6 years

First QC Date

November 25, 2014

Last Update Submit

March 5, 2019

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderExecutive FunctionrTMS (Repetitive Transcranial Magnetic Stimulation)MRI (Magnetic Resonance Imaging)Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Change in accuracy on the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Task

    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 Outcomes (1)

  • Change in scores on Behaviour Rating Inventory of Executive Functioning (A) (BRIEF) (A)

    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)

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

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

Sham rTMS

SHAM COMPARATOR

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

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.

Also known as: MagPro x100 series (Medtronic A/S, Copenhagen, Denmark)
Active rTMSSham rTMS

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Are fluent in the English language
  • Competent to consent
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addictions and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (2)

  • Moxon-Emre I, Daskalakis ZJ, Blumberger DM, Croarkin PE, Lyon RE, Forde NJ, Tani H, Truong P, Lai MC, Desarkar P, Sailasuta N, Szatmari P, Ameis SH. Modulation of Dorsolateral Prefrontal Cortex Glutamate/Glutamine Levels Following Repetitive Transcranial Magnetic Stimulation in Young Adults With Autism. Front Neurosci. 2021 Oct 6;15:711542. doi: 10.3389/fnins.2021.711542. eCollection 2021.

    PMID: 34690671DERIVED

  • Ameis SH, Blumberger DM, Croarkin PE, Mabbott DJ, Lai MC, Desarkar P, Szatmari P, Daskalakis ZJ. Treatment of Executive Function Deficits in autism spectrum disorder with repetitive transcranial magnetic stimulation: A double-blind, sham-controlled, pilot trial. Brain Stimul. 2020 May-Jun;13(3):539-547. doi: 10.1016/j.brs.2020.01.007. Epub 2020 Jan 15.

    PMID: 32289673DERIVED

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Stephanie H Ameis, M.D., M.S.C

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 8, 2014

Study Start

October 1, 2014

Primary Completion

May 4, 2018

Study Completion

May 4, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)