rTMS to Improve Motor Function in Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCentre for Addiction and Mental Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Active rTMS to the motor cortex
DeviceActive bilateral repetitive transcranial magnetic stimulation to the motor cortex
Sham rTMS to the motor cortex
DeviceSham bilateral repetitive transcranial magnetic stimulation to the motor cortex
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Active rTMSActive comparator 1 intervention
Group B: Sham rTMSSham comparator 1 intervention
Trial outcomes
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.
Time frame
Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.Secondary outcomes
1
Changes in motor cortical plasticity using cortical evoked activity (CEA) in autistic adults following rTMS.
A secondary measure of plasticity will be indexed by the maximum post-iTBS/pre-iTBS cortical evoked activity (CEA) ratio. CEA will be defined as the area under rectified curve for averaged electroencephalography (EEG) recordings in the electrode over motor cortex between 50-275 millisecond post-stimulus.
Time frame
Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.2
Changes in the adaptive daily living skills in autistic adults following rTMS.
The daily living skills domain of Adaptive Behavior Assessment System-3rd edition will be used to assess adaptive daily living skills. A higher score represents better adaptive skills.
Time frame
Adaptive daily living skills will be assessed at baseline and the day after the final rTMS session.3
Changes in motor function in autistic adults following rTMS.
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) will be used to assess motor function. The total motor composite score will be used as the primary measure of motor function. A higher score on BOT-2 indicates better motor performance.
Time frame
Motor function will be assessed at baseline and the day after the final rTMS.Sponsors and contacts
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Source ClinicalTrials.gov