Study Results
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Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2020-09-01
2026-07-16
Brief Summary
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Detailed Description
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120 stroke subjects within 3 weeks post-stroke will be recruited from National University Hospital (NUH), Alexandra Hospital (AH), and Tan Tock Seng Hospital (TTSH). We will follow changes in cortical activity over time using Transcranial Magnetic Stimulation (TMS), MRI and EEG measures and correlate these with clinical outcome measures at the same time points, to study the interaction between neural excitability and functional outcome.
10 healthy subjects will be needed as control group to compare outcomes obtained from MRI scans.
Outcome measures of brain corticospinal excitability, clinical measures on upper limb motor function and cognitive tests, will be performed 4 times- within 4 weeks, at 3 months, 6 months and 1 year after stroke onset, except for MRI which will not be performed at 1 year after stroke onset.
Subjects from Study 1 whose ARAT (Action Research Arm test) score is \< = 42 at 3 months post-stroke will proceed to Study 2. ARAT score \< = 42 indicates limited functional capacity and below. The aim of Study 2 is to investigate the efficacy and the neurophysiological effects of 2 types of tDCS protocols in facilitating upper limb motor recovery in patients with significant limitations in upper limb function.
There are a total of 4 groups in Study 2. Subjects who are agreeable for transcranial direct current stimulation (tDCS) will be randomized into 3 groups with 17 subjects in each group, by stratified randomization using Microsoft Excel, according to the lesion location (cortical vs. subcortical), and type of stroke (haemorrhagic vs. ischemic). Subjects who refuse tDCS will be enrolled in the control group without receiving any tDCS stimulation.
* Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
* Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
* Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
* Group 4: Subjects who fulfill the inclusion criteria of Study 2 but refuse tDCS stimulation.
Cathode for all 3 tDCS groups will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training. Subjects in Study 2 will continue with the 6-month and 1 year assessment, as in Study 1.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
* Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
* Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
* Group 4: Subjects who fulfill the inclusion criteria of Study 2 but refuse tDCS stimulation.
OTHER
SINGLE
Study Groups
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Anodal tDCS stimulation to the ipsilesional M1
Participant will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
trancranial magnetic stimulation
A trained research staff or physician will perform tDCS to the subject. Direct current will be delivered by a battery-operated, constant current stimulator, through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 20 minutes, and then ramped down to 0 mA over 30 seconds.
Anodal tDCS to the contralesional premotor cortex
Participant will receive 1mA anodal tDCS to the contralesional premotor cortex. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
trancranial magnetic stimulation
A trained research staff or physician will perform tDCS to the subject. Direct current will be delivered by a battery-operated, constant current stimulator, through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 20 minutes, and then ramped down to 0 mA over 30 seconds.
Sham tDCS
Participant will receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
trancranial magnetic stimulation
A trained research staff or physician will perform tDCS to the subject. Direct current will be delivered by a battery-operated, constant current stimulator, through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 20 minutes, and then ramped down to 0 mA over 30 seconds.
Control group
Subjects who fulfill the inclusion criteria of Study 2 but refuse tDCS stimulation.
No interventions assigned to this group
Interventions
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trancranial magnetic stimulation
A trained research staff or physician will perform tDCS to the subject. Direct current will be delivered by a battery-operated, constant current stimulator, through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 20 minutes, and then ramped down to 0 mA over 30 seconds.
Eligibility Criteria
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Inclusion Criteria
2. First ever stroke less than 6 weeks;
3. Moderate to severe upper limb impairment with Manual Muscle Testing (MMT) score on shoulder abduction plus finger extension (SAFE) \<5 within the first week post-stroke.
1. Age 21-80 years old;
2. No known medical history.
Exclusion Criteria
2. Any metal implants inside the body that are contraindications of MRI scan;
3. cardiac pacemakers;
4. History of epilepsy;
5. Sensorimotor disturbance due to other causes other than stroke;
6. Claustrophobia;
7. Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
8. Major depression and a history of psychotic disorders;
9. Terminal diagnosis with life expectancy \<=1 year.
1. Pregnancy;
2. Any metal implants inside the body that are contraindications of MRI scan;
3. cardiac pacemakers;
4. Claustrophobia.
21 Years
80 Years
ALL
Yes
Sponsors
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Alexandra Hospital
OTHER
National University of Singapore
OTHER
Nanyang Technological University
OTHER
National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Effie Chew, MBBS
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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Alexandra Hospital
Singapore, , Singapore
National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019/00932
Identifier Type: -
Identifier Source: org_study_id
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