High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Application of High-definition Transcranial Electrical Stimulation in the Upper Extremity Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: HD-tCES; Other: Upper extremity rehabilitation; Device: Sham HD-tCES

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Taipei, Taiwan
    • Taipei Municipal Wanfang Hospital - Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 20 years.
2. Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
3. 6 months to 5 years after stroke.
4. Muscular inelasticity (spasticity) 1-3 on the affected upper limb, evaluated by the Modified Ashworth Scale.

Exclusion Criteria:

1. Extremely sensitive to electrical stimulation and cannot tolerate it.
2. Contracture on upper extremities, and limitation in joint range of motion.
3. The muscle tone was severe spasticity,
4. Ossification or inflammation in muscle tissue.
5. A history of cardiopulmonary disease or arrhythmia.
6. With implantable medical electronic devices, like pacemaker.
7. Pressure sores or wounds on the skin of head and upper extremities.
8. Metal implants in the head (neck).
9. Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
10. A history of seizure or other brain pathology.
11. Brain surgery or severe brain trauma.
12. Drug or alcohol abuse.
13. Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HD-tCES & upper extremity rehabilitation; The experiment group will receive HD-tCES combined with upper extremity rehabilitation of affected side.	Device: HD-tCES; 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.; Other: Upper extremity rehabilitation; 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.
Sham Comparator: Sham HD-tCES & upper extremity rehabilitation; The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.	Other: Upper extremity rehabilitation; 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.; Device: Sham HD-tCES; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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	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.	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]	Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.	Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks)

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: National Cheng Kung University; Ministry of Science and Technology, R.O.C (Taiwan)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 12, 2021
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Stroke, Transcranial electrical stimulation, Upper-limb rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: N201909051; MOST-108-2321-B-038-002 (Other Grant/Funding Number: Ministry of Science and Technology, R.O.C. (Taiwan))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No