rTMS to Improve Motor Function in Autism

NCT06497920 | Recruiting

• 1 other identifier: 2023/180
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.

Conditions

Autism Spectrum Disorder; Motor Activity

Keywords

Autism; Motor Function; Repetitive Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation; Motor Cortex; Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Changes in motor cortical plasticity using motor evoked potentials (MEPs) in autistic adults following rTMS.

  Plasticity will be indexed by the duration of facilitation of motor evoked potentials (MEPs) amplitude, i.e. the time for the MEP amplitude to return to baseline values following iTBS.

  Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.

Secondary Outcomes (3)

• Changes in motor cortical plasticity using cortical evoked activity (CEA) in autistic adults following rTMS.

  Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.

• Changes in the adaptive daily living skills in autistic adults following rTMS.

  Adaptive daily living skills will be assessed at baseline and the day after the final rTMS session.

• Changes in motor function in autistic adults following rTMS.

  Motor function will be assessed at baseline and the day after the final rTMS.

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Autistic adults receiving active rTMS to the motor cortex.

Device: Active rTMS to the motor cortex

Sham rTMS

SHAM COMPARATOR

Autistic adults receiving sham rTMS to the motor cortex.

Device: Sham rTMS to the motor cortex

Interventions

Active rTMS to the motor cortex DEVICE

Active bilateral repetitive transcranial magnetic stimulation to the motor cortex

Active rTMS

Sham rTMS to the motor cortex DEVICE

Sham bilateral repetitive transcranial magnetic stimulation to the motor cortex

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 40 years old. 40 years is chosen as the cut-off because of the report of high rates of Parkinsonism in autistic adults \> 39years;
• Have IQ\>70;
• Are able to read, write and communicate effectively in English;
• Are able to provide informed consent. We will recruit only intellectually-able autistic adults. The intellectual ability will be determined using WASI-II. The ability to provide consent will be determined using clinical assessment.
• Have no prior history of seizure;
• Must sign and date the informed consent form;
• Stated willingness to comply with all study procedures;
• Agreement to adhere to Lifestyle Considerations, that is: refrain from consumption of alcohol, tobacco, marijuana, or caffeine on the day of study visits.
• All ASD participants:
• Will have DSM-5 diagnosis of ASD without intellectual disability, confirmed by clinical assessment and the Autism Diagnostic Observation Schedule - 2 (ADOS-2);
• Will have significant motor function difficulties defined as a standard composite score \<40 (i.e., \>1 standard deviation below the mean) on either fine or gross motor composite scores of the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition or BOT-2;
• Are clinically stable as determined by clinical assessment, with no medication changes over the past 4 weeks. Given the high variability of handedness in ASD, we will include participants with left, right or mixed handedness.

You may not qualify if:

• ASD or control participants will be excluded if they experience/have:
• Current pregnancy;
• Current or past history of co-morbid medical condition that may require urgent medical intervention;
• DSM-5 substance use disorder (other than tobacco) within the past 6 months; however, all participants will be asked to refrain from smoking or taking caffeine four hours prior to the iTBS session;
• Significant hearing or visual impairment interfering with the ability to read or hear instructions;
• Significantly debilitating medical or neurologic illness (e.g., encephalitis, aneurysms, tumors, central nervous system infections), or acute or unstable medical illnesses as determined by project physician (e.g., uncontrolled diabetes);
• Metal implants or a pace-maker;
• Prior rTMS treatment;
• In addition, ASD participants will be excluded if they report taking benzodiazepines or anticonvulsants currently.
• NT controls will be excluded if they have:
• Presence of psychopathology other than specific phobia, as screened by Personality Assessment Inventory and;
• A known diagnosis of Pervasive Developmental Disorder or ASD among any biologically related family members.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Motor Activity; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Central Study Contacts

Pushpal Desarkar, MD

CONTACT

4165358501; Pushpal.Desarkar@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent assistant external to the project will manage the randomization of subjects. The clinician, investigators, participant and research staff will all be blinded. To ensure blinding during treatment, either the active or sham adapter will be connected to the Magstim Horizon, and the coil will remain the same. To maintain blinding of both the research staff and the participant, the TMS lab research staff will attach the device adapter corresponding to the assigned randomization code received from the Code Custodian. The code lists for Active and Sham interventions have been attached to the respective adapters by an independent Centre member, and all study members and TMS lab research staff remain blinded to the actual intervention. Both adaptors have identical external appearances, and stimulation of either coil generates identical auditory and somatosensory (vibration) stimuli. All raters obtaining outcome measures will also be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project includes a randomized controlled trial. We will use a randomized, double- blind, sham-controlled design comparing the efficacy of active vs. sham rTMS (6000 pulses at 20 Hz/session, 3000 pulses/hemisphere with 5-10 min break in between) delivered to the motor cortex using bilaterally, 1 session/day for 3 consecutive days (3 sessions). Pulses will be delivered to one hemisphere (left or right) first, followed by the opposite side. The sequence will be randomized for each participant.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 12, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

CA (1)