High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation
Application of High-definition Transcranial Electrical Stimulation in the Upper Extremity Rehabilitation
2 other identifiers
interventional
24
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Mar 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2021
CompletedApril 1, 2021
March 1, 2021
1 year
February 18, 2020
March 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Secondary Outcomes (5)
Change from baseline in the Wolf Motor Function Test (WMFT) after intervention
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Modified Ashworth Scale (MAS) after intervention
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Finger to Nose Test after intervention
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Incidence of treatment-emergent adverse events [safety and tolerability]
Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks)
Study Arms (2)
HD-tCES & upper extremity rehabilitation
EXPERIMENTALThe experiment group will receive HD-tCES combined with upper extremity rehabilitation of affected side.
Sham HD-tCES & upper extremity rehabilitation
SHAM COMPARATORThe sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 20 years.
- Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- months to 5 years after stroke.
- Muscular inelasticity (spasticity) 1-3 on the affected upper limb, evaluated by the Modified Ashworth Scale.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Medical Universitylead
- Ministry of Science and Technology, Taiwancollaborator
- National Cheng Kung Universitycollaborator
Study Sites (3)
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Municipal Wanfang Hospital - Taipei Medical University
Taipei, Taiwan
Related Publications (2)
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.
PMID: 36047662DERIVEDWang 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.
PMID: 34479230DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
March 1, 2020
Primary Completion
March 12, 2021
Study Completion
March 12, 2021
Last Updated
April 1, 2021
Record last verified: 2021-03