Stroke Clinical Trial
Official title:
Effects of Theta Burst Stimulation on Modulation of Mirror Illusion-induced Rhythm Suppression in Stroke
Verified date | November 2020 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to test the hypothesis that rTMS in the form of theta burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke
Status | Completed |
Enrollment | 36 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. type and location of stroke - ischemic or hemorrhagic, cortical or subcortical, confirmed by medical diagnoses compatible with a unilateral lesion involvement; 2. Acute stroke patients: stroke with onset of neurological condition =3 months, recruited from a local hospital; Chronic stroke patients: stroke with onset of neurological condition from 6 months to 3 years, recruited from self-help organization in the community. The randomization will be pre-stratified into 2 - subacute and chronic stages, and recruit from 2 centers - acute hospital and self-help organizations in the community. 3. normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye; 4. right-handed, verified by the Edinburgh Handedness Inventory; 5. mild to moderately impaired hemiplegic upper extremity functions, with functional levels 5-7 as rated by the Functional Test for the Hemiplegic Upper Extremity - Hong Kong version (FTHUE-HK); 6. the ability to understand and follow simple verbal instructions; 7. the ability to participate in a therapy session lasting at least 60 minutes; and 8. consent to participate in the study. Exclusion Criteria: 1. prior neurological or psychiatric disorders; 2. severe spasticity (Modified Ashworth Scale >3) over hemiplegic upper extremity; 3. a history of recent Botox injections or acupuncture to the hemiplegic upper extremity within the past three months; 4. use of central nervous system-active medicine; 5. any contraindication to TMS, according to the guideline of the Safety of TMS Consensus group, such as the risk of epilepsy, metal implants, and pregnancy; 6. the presence of unilateral neglect as screened by the Behavioural Inattention Test (CBIT-HK); and 7. participation in another clinical study elsewhere during recruitment. Informed written consent will be obtained from all patients prior to data collection. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Kenneth FONG | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University | Queen Mary Hospital, Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer assessment (FMA) | A stroke-specific, performance-based impairment index | Baseline | |
Primary | Fugl-Meyer assessment (FMA) | A stroke-specific, performance-based impairment index | 1 day | |
Primary | Fugl-Meyer assessment (FMA) | A stroke-specific, performance-based impairment index | 2 weeks | |
Primary | Fugl-Meyer assessment (FMA) | A stroke-specific, performance-based impairment index | 1-month after the completion of the intervention | |
Primary | Action Research Arm Test (ARAT) | A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery | Baseline (immediately before the first session) | |
Primary | Action Research Arm Test (ARAT) | A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery | 1 day | |
Primary | Action Research Arm Test (ARAT) | A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery | 2 weeks | |
Primary | Action Research Arm Test (ARAT) | A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery | 1-month after the completion of the intervention | |
Secondary | EEG rhythm power | Rhythm power desynchronization/synchronization in response to mirror visual feedback | Baseline (immediately before the first session) | |
Secondary | EEG rhythm power | Rhythm power desynchronization/synchronization in response to mirror visual feedback | 1 day | |
Secondary | EEG rhythm power | Rhythm power desynchronization/synchronization in response to mirror visual feedback | 2 weeks | |
Secondary | EEG rhythm power | Rhythm power desynchronization/synchronization in response to mirror visual feedback | 1-month after the completion of the intervention | |
Secondary | Motor-evoked Potential (MEP) | Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex. | Baseline (immediately before the first session) | |
Secondary | Motor-evoked Potential (MEP) | Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex. | 1 day | |
Secondary | Motor-evoked Potential (MEP) | Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex. | 2 weeks | |
Secondary | Motor-evoked Potential (MEP) | Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex | 1-month after the completion of the intervention | |
Secondary | Cortical silent period | The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex. | Baseline (immediately before the first session) | |
Secondary | Cortical silent period | The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex. | 1 day | |
Secondary | Cortical silent period | The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex. | 2 weeks | |
Secondary | Cortical silent period | The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex. | 1-month after the completion of the intervention | |
Secondary | Ipsilateral silent period | Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex. | Baseline (immediately before the first session) | |
Secondary | Ipsilateral silent period | Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex. | 1 day | |
Secondary | Ipsilateral silent period | Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex. | 2 weeks | |
Secondary | Ipsilateral silent period | Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex. | 1-month after the completion of the intervention |
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