- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821884
Combine Transcranial Direct Current Stimulation and Neuromuscular Electrical Stimulation on Stroke Patients
Study Overview
Status
Conditions
Detailed Description
The Transcranial direct current stimulation (tDCS) and neuromuscular electrical stimulation (NMES) is non-invasive electrical stimulation, and some studies have proved efficacy of the tDCS and NMES on healthy subjects and stroke patients. However, the effects of combination tDCS and NMES on upper extremity motor recovery and neural plasticity in healthy subjects and patients with stroke have not yet been investigated. Moreover in order to discover the tDCS combine NMES of the safety and feasibility and influences on neural plasticity and motor function, the cortical excitability and functional recovery measurements (clinical scales) are taken in the healthy subjects and stroke.
The right-handed subjects will be received the combination of tDCS and NMES for 30 minutes. The changes in the hand function and cortical excitability were probed by recording movement performance scales in upper extremity and mapping of brain cortex before and after the intervention.
The patients will be assigned into one of three groups (A, B,C) by block randomization. All participants will receive regular traditional rehabilitation. In addition, three groups will receive an additional 3 weeks, 5 times per week, 30 minutes once daily, total 15 session. Group A: both tDCS and NMES conduct simultaneously for 30 minutes. Group B: combination of tDCS and sham NMES Group C: combination of sham tDCS and sham NMES.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria(healthy subjects):
- Age: 20~65 years old
- Who are willing to participate in the experiment
- Signed the consent
- Right handed
Exclusion Criteria(healthy subjects):
- Musculoskeletal pathology or neurological disorders affecting movements in the upper limbs
- Epilepsy or family history
- Cardiac pacemaker
- Metallic implant in the head
- Pregnancy
- Sensory complete injury in upper limb
- Had brain surgery
- Expected to conduct brain surgery and major surgery during the experiment
- The patients is suitable for the experiment by investigator assessedInclusion
Inclusion Criteria(stroke):
- Signed the informed consent
- First-ever ischemic stroke
- Stroke at least 6 months
- Unilateral hemiplegia
- No severe cognitive impairment (National Institutes of Health Stroke Scale-Level of Consciousness: 0, Level of Consciousness Questions: 0, Level of Consciousness Commands: 0)
- Sit on a chair for more than 30 minutes independently
- Brunnstrom recovery stage≧3 in the paretic hand
- Muscle tone at the wrist flexor with a modified Ashworth scale≦2
Exclusion Criteria(stoke):
- Speech disorder or global aphasia
- Musculoskeletal pathology or neurological disorders affecting movements in the paretic upper limbs
- Epilepsy or family history
- Cardiac pacemaker
- Metallic implant in the head
- Pregnancy
- Diabetic, peripheral vascular disease or neuropathy that attributable to sensory complete injury
- Have intracranial space occupied lesion, ex: brain tumors, arteriovenous malformations
- Had brain surgery
- Meningitis and encephalitis
- Expected to conduct brain surgery and major surgery during the experiment
- The patients is suitable for the experiment by investigator assessed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combination of tDCS and NMES
Both tDCS and NMES conduct simultaneously for 30 minutes.
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Both tDCS and NMES conduct simultaneously for 30 minutes.
The anodal electrode of tDCS is placed on the scalp site corresponding to primary motor cortex (M1) of the hemisphere affected by stroke.
The cathodal electrode of tDCS is placed on the scalp site corresponding to unaffected primary motor cortex.
The current is initially increased in a ramp-like fashion over 30 seconds until reaching 2 mA and is decreased ramp-like fashion over 30 seconds until reaching 0 mA.
The NMES electrodes are placed over the following muscle: extensor digitorum communis, extensor carpi radialis to produce wrist and hand extension.
The settings for the NMES is frequency at 50 Hz, pulse width of 200μs,duty cycle of 10 seconds on and 10 seconds off,current amplitude is adjusted to patients comfort (10-20mA).
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Active Comparator: Combination of tDCS and sham NMES
Both tDCS and sham NMES conduct simultaneously for 30 minutes.
Sham NMES electrodes are placed away from all motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation.
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Both tDCS and sham NMES conduct simultaneously for 30 minutes.
The anodal electrode of tDCS is placed on the scalp site corresponding to primary motor cortex (M1) of the hemisphere affected by stroke.
The cathodal electrode of tDCS is placed on the scalp site corresponding to unaffected primary motor cortex.
The current is initially increased in a ramp-like fashion over 30 seconds until reaching 2 mA and is decreased ramp-like fashion over 30 seconds until reaching 0 mA.
Sham NMES electrodes are placed away from all extensor digitorum communis, extensor carpi radialis motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation(wrist extension).
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Sham Comparator: Combination of sham tDCS and sham NMES
Both sham tDCS and sham NMES conduct simultaneously for 30 minutes. Shame tDCS is started in a ramp-like fashion but fade out slowly after 30 seconds. Sham NMES electrodes are placed away from all motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation. |
Both sham tDCS and sham NMES conduct simultaneously for 30 minutes.
Sham tDCS electrodes are placed in the same position on patients receiving the sham stimulation.
Just like during real tDCS, stimulation is started in a ramp-like fashion but fade out slowly after 30 seconds.
Sham NMES electrodes are placed away from all extensor digitorum communis, extensor carpi radialis motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation(wrist extension).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement performance assessment
Time Frame: Change from baseline motor performance at 3 weeks, 1 month and 6 months.
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Movement performance assessment by clinical motor assessment scales in upper extremity executed by qualified physiotherapy in 3 groups.
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Change from baseline motor performance at 3 weeks, 1 month and 6 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mapping of brain cortex
Time Frame: Change from baseline motor performance at 3 weeks, 1 month and 6 months.
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This examination is optional use equipment of brain mapping (single pulse transcranial magnetic stimulation) and operated under trained staff, the attending is consulted.
This examination can be stopped at any time if participants do not want to perform or feeling unwell.
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Change from baseline motor performance at 3 weeks, 1 month and 6 months.
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Collaborators and Investigators
Investigators
- Principal Investigator: Jau-Hong Lin, Professor, Kaohsiung Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-F(I)-20150053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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