High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: HD-tCES; Device: Sham HD-tCES; Other: Upper extremity rehabilitation

• Registration Number: NCT04278105
• Lead Sponsor: Taipei Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-20
• Study Start: 2020-03-01
• Status Verified: 2021-03
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HD-tCES & upper extremity rehabilitation	HD-tCES	The experiment group will receive HD-tCES combined with upper extremity rehabilitation of affected side.
HD-tCES & upper extremity rehabilitation	Upper extremity rehabilitation	The experiment group will receive HD-tCES combined with upper extremity rehabilitation of affected side.
Sham HD-tCES & upper extremity rehabilitation	Sham HD-tCES	The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.
Sham HD-tCES & upper extremity rehabilitation	Upper extremity rehabilitation	The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) 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)	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

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

Trial Locations

Locations (3)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Municipal Wanfang Hospital - Taipei Medical University; 🇨🇳 Taipei, Taiwan

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare; 🇨🇳 New Taipei City, Taiwan