- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431749
The Use of Dual-coil Transcranial Magnetic Stimulation to Measure and Modulate Poststroke Interhemispheric Inhibition.
Using Dual-coil Transcranial Magnetic Stimulation to Measure and Modulate Poststroke Interhemispheric Inhibition (IHI): A Concurrent TMS-EEG-EMG Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: JIAQI JACK Zhang, PhD
- Phone Number: 27666696
- Email: jack-jiaqi.zhang@polyu.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- Hong Kong Polytechnic University
-
Hong Kong, Hong Kong
- Not yet recruiting
- The Hong Kong Polytechnic University
-
Contact:
- JIAQI JACK Zhang, PhD
- Phone Number: 27666696
- Email: jack-jiaqi.zhang@polyu.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1) have a diagnosis of ischemic or hemorrhagic stroke, with time after stroke onset≥6 months. For stroke patients, we will invite participants to receive a structural magnetic resonance imaging (MRI) at the University Research Facility in Behavioral and Systems Neuroscience to verify their actual lesion location; (2) aged between 18 and 80 years old; (3) with residual upper limb functions from 4-7 levels in the Functional Test for the Hemiplegic Upper Extremity (Hong Kong version); (4) have evocable MEP from both M1; (5) able to give informed written consent to participate in the study. (6) able to understand and communicate with Chinese.
Exclusion Criteria:
(1) any contraindications to TMS (screened by the safety checklist by Rossi); (2) any concomitant neurological disease; (3) any sign of moderate-to-severe cognitive problems, i.e., the abbreviated mental test Hong Kong version<6 out of 10 points [22]; and (4) Modified Ashworth score>2 in hand, wrist or elbow extensor muscle in their hemiparetic upper limbs.
In addition, a group of right-hand-dominant healthy adults, without any known neurological and psychiatric diseases, will be enrolled.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ccPAS (8ms)
ccPAS session will involve 180 paired pulses repeated at a frequency of 0.2Hz (approximately 15 minutes), stimulating the ipsilesional M1 8ms after the first pulse over the contralesional M1, during premovement stage.
|
The ccPAS will be applied using a MagPro X100/R30 stimulator and a MagPro R20/R30 extension connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation.
|
|
Experimental: ccPAS (12ms)
ccPAS session will involve 180 paired pulses repeated at a frequency of 0.2Hz (approximately 15 minutes), stimulating the ipsilesional M1 12ms after the first pulse over the contralesional M1, during premovement stage.
|
The ccPAS will be applied using a MagPro X100/R30 stimulator and a MagPro R20/R30 extension connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation.
|
|
Sham Comparator: Sham ccPAS
ccPAS session will involve 180 paired pulses repeated at a frequency of 0.2Hz (approximately 15 minutes), stimulating the ipsilesional M1 100ms after the first pulse over the contralesional M1, during premovement stage.
|
The ccPAS will be applied using a MagPro X100/R30 stimulator and a MagPro R20/R30 extension connected to two vertically oriented figure-of-eight coils designed for bilateral hemispheric stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
transcranial magnetic stimulation-evoked potential in electroencephalography (TMS-EEG)
Time Frame: Baseline
|
The amplitude of P30 (28-35ms) will be extracted from the artifact-free TEP trials to represent the cortical excitatory activity.
|
Baseline
|
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Transcranial magnetic stimulation-evoked potential in electroencephalography
Time Frame: After stimulation (15 mins post)
|
The amplitude of P30 (28-35ms) will be extracted from the artifact-free TEP trials to represent the cortical excitatory activity.
|
After stimulation (15 mins post)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20251026002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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