Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497920
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-13
Brief Title:
rTMS to Improve Motor Function in Autism
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Modulating Plasticity in the Motor Cortex Using Repetitive Transcranial Magnetic Stimulation to Improve Motor Function in Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the current project investigators have two main goals i Testing whether an excessive plasticity ie 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
Detailed Description:
Autism spectrum disorder ASD is a very common developmental condition yet the cause remains unknown and effective treatment options to improve outcomes remain limited Most autistic adults experience significant motor function difficulties involving balance posture coordination and strength that negatively affect their quality of life social interaction confidence and daily functioning Therefore such difficulties remain an important treatment target However there are no known effective clinical interventions for such difficulties Investigators previously showed that the part of the brain that controls motor movements ie motor cortex showed hyperplasticity as assessed by theta-burst magnetic brain stimulation TBS in autistic adults Hyperplasticity may adversely affect brain health and behavior Investigators also previously found that rTMS may reduce such hyperplasticity in the motor cortex in autistic adults
In this project 100 autistic adults with significant motor function difficulties and 50 neurotypical NT controls matched 21 based on age sex and IQ will be recruited At the Centre for Addiction and Mental Health Toronto each autistic adults participation will consist of nine visits while each NT adults participation will include two visits
All participants both autistic and NT will undergo clinical adaptive and motor function assessments during their first visit lasting approximately 3 hours and a pre- and post-intermittent-TBS iTBS session with electroencephalography EEG to induce and assess plasticity in the left or right motor cortex depending on handedness during their second visit lasting approximately 25 hours Based on the preliminary evidence that rTMS reduces hyperplasticity in the motor cortex in autistic adults the investigators will then use a randomized double-blind sham-controlled design for bilateral 5-session rTMS on the motor cortex Autistic participants will be randomized 11 sex-stratified to receive either active or sham rTMS 120 trains of 50 pulses with an inter-train interval of 30 seconds delivered at 90 of the resting motor threshold for both conditions five days a week approximately 1 hour each from their third to seventh visits total of 5 sessions Assessment of motor and adaptive function and plasticity in the motor cortex will be repeated immediately one week eighth visit and four weeks ninth visit after the last rTMS session ie 5th session
In this project 100 autistic adults with significant motor function difficulties and 50 neurotypical NT controls matched 21 based on age sex and IQ will be recruited At the Centre for Addiction and Mental Health Toronto each autistic adults participation will consist of nine visits while each NT adults participation will include two visits
All participants both autistic and NT will undergo clinical adaptive and motor function assessments during their first visit lasting approximately 3 hours and a pre- and post-intermittent-TBS iTBS session with electroencephalography EEG to induce and assess plasticity in the left or right motor cortex depending on handedness during their second visit lasting approximately 25 hours Based on the preliminary evidence that rTMS reduces hyperplasticity in the motor cortex in autistic adults the investigators will then use a randomized double-blind sham-controlled design for bilateral 5-session rTMS on the motor cortex Autistic participants will be randomized 11 sex-stratified to receive either active or sham rTMS 120 trains of 50 pulses with an inter-train interval of 30 seconds delivered at 90 of the resting motor threshold for both conditions five days a week approximately 1 hour each from their third to seventh visits total of 5 sessions Assessment of motor and adaptive function and plasticity in the motor cortex will be repeated immediately one week eighth visit and four weeks ninth visit after the last rTMS session ie 5th session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None