Back to resultsHigh-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HD-tCES
Sham HD-tCES
Upper extremity rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Transcranial electrical stimulation, Upper-limb rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 20 years.
- Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Muscular inelasticity (spasticity) 1-3 on the affected upper limb, evaluated by the Modified Ashworth Scale.
Exclusion Criteria:
- Extremely sensitive to electrical stimulation and cannot tolerate it.
- Contracture on upper extremities, and limitation in joint range of motion.
- The muscle tone was severe spasticity,
- Ossification or inflammation in muscle tissue.
- A history of cardiopulmonary disease or arrhythmia.
- With implantable medical electronic devices, like pacemaker.
- Pressure sores or wounds on the skin of head and upper extremities.
- Metal implants in the head (neck).
- Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
- A history of seizure or other brain pathology.
- Brain surgery or severe brain trauma.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
Sites / Locations
- Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
- Taipei Medical University Hospital
- Taipei Municipal Wanfang Hospital - Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
HD-tCES & upper extremity rehabilitation
Sham HD-tCES & upper extremity rehabilitation
Arm Description
The experiment group will receive HD-tCES combined with upper extremity rehabilitation of affected side.
The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.
Outcomes
Primary Outcome Measures
Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
The FMA-UE assesses motor functioning of upper extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
Secondary Outcome Measures
Change from baseline in the Wolf Motor Function Test (WMFT) after intervention
The WMFT assesses upper extremity motor ability through timed and functional tasks. The items are rated on a 6-point scale (0-1-2-3-4-5). The total score of the WMFT is 75, with higher scores indicating higher functioning levels.
Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
The JTT assesses hand functions commonly used in activities of daily living. The subtests are scored according to time taken to complete the task. Total score is the sum of time taken for each subtest, with shorter times indicating better performance.
Change from baseline in the Modified Ashworth Scale (MAS) after intervention
The MAS is commonly used in clinical practice for grading spasticity. The MAS is rated on a 6-point scale (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension. The muscles being assessed include shoulder abductor, elbow flexor, elbow extensor, wrist flexor, and finger flexor.
Change from baseline in the Finger to Nose Test after intervention
The Finger to Nose Test assesses coordination of upper-extremity movement. The number of complete nose-target movements during a 20-second period will be recorded.
Incidence of treatment-emergent adverse events [safety and tolerability]
Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.
Full Information
NCT ID
NCT04278105
First Posted
February 18, 2020
Last Updated
March 30, 2021
Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, R.O.C (Taiwan), National Cheng Kung University
1. Study Identification
Unique Protocol Identification Number
NCT04278105
Brief Title
High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation
Official Title
Application of High-definition Transcranial Electrical Stimulation in the Upper Extremity Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, R.O.C (Taiwan), National Cheng Kung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However,the existing tCES products effect on the whole brain networks and lack special waveforms. Therefore, we aim to develop a wearable tCES with high definition and special waveforms in this study. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. We expect that the novel high-definition tCES (HD-tCES) combined with the upper extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Transcranial electrical stimulation, Upper-limb rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HD-tCES & upper extremity rehabilitation
Arm Type
Experimental
Arm Description
The experiment group will receive HD-tCES combined with upper extremity rehabilitation of affected side.
Arm Title
Sham HD-tCES & upper extremity rehabilitation
Arm Type
Sham Comparator
Arm Description
The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.
Intervention Type
Device
Intervention Name(s)
HD-tCES
Intervention Description
The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Sham HD-tCES
Intervention Description
The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
Intervention Type
Other
Intervention Name(s)
Upper extremity rehabilitation
Intervention Description
Upper extremity rehabilitation programs will be selected and graded in accordance with each patient's upper extremity function and specific aims of activities of daily living. Upper extremity rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
Description
The FMA-UE assesses motor functioning of upper extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Secondary Outcome Measure Information:
Title
Change from baseline in the Wolf Motor Function Test (WMFT) after intervention
Description
The WMFT assesses upper extremity motor ability through timed and functional tasks. The items are rated on a 6-point scale (0-1-2-3-4-5). The total score of the WMFT is 75, with higher scores indicating higher functioning levels.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
Description
The JTT assesses hand functions commonly used in activities of daily living. The subtests are scored according to time taken to complete the task. Total score is the sum of time taken for each subtest, with shorter times indicating better performance.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Change from baseline in the Modified Ashworth Scale (MAS) after intervention
Description
The MAS is commonly used in clinical practice for grading spasticity. The MAS is rated on a 6-point scale (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension. The muscles being assessed include shoulder abductor, elbow flexor, elbow extensor, wrist flexor, and finger flexor.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Change from baseline in the Finger to Nose Test after intervention
Description
The Finger to Nose Test assesses coordination of upper-extremity movement. The number of complete nose-target movements during a 20-second period will be recorded.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Incidence of treatment-emergent adverse events [safety and tolerability]
Description
Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.
Time Frame
Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 20 years.
Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
6 months to 5 years after stroke.
Muscular inelasticity (spasticity) 1-3 on the affected upper limb, evaluated by the Modified Ashworth Scale.
Exclusion Criteria:
Extremely sensitive to electrical stimulation and cannot tolerate it.
Contracture on upper extremities, and limitation in joint range of motion.
The muscle tone was severe spasticity,
Ossification or inflammation in muscle tissue.
A history of cardiopulmonary disease or arrhythmia.
With implantable medical electronic devices, like pacemaker.
Pressure sores or wounds on the skin of head and upper extremities.
Metal implants in the head (neck).
Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
A history of seizure or other brain pathology.
Brain surgery or severe brain trauma.
Drug or alcohol abuse.
Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
City
New Taipei City
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Taipei Municipal Wanfang Hospital - Taipei Medical University
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
36047662
Citation
Huang YJ, Wang SM, Chen C, Chen CA, Wu CW, Chen JJ, Peng CW, Lin CW, Huang SW, Chen SC. High-Definition Transcranial Direct Current with Electrical Theta Burst on Post-Stroke Motor Rehabilitation: A Pilot Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Sep;36(9):645-654. doi: 10.1177/15459683221121751. Epub 2022 Sep 1.
Results Reference
derived
PubMed Identifier
34479230
Citation
Wang SS, Huang YJ, Chen JJ, Wu CW, Chen CA, Lin CW, Nguyen VT, Peng CW. Designing and pilot testing a novel high-definition transcranial burst electrostimulation device for neurorehabilitation. J Neural Eng. 2021 Sep 17;18(5). doi: 10.1088/1741-2552/ac23be.
Results Reference
derived
Learn more about this trial
High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation
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