High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278105
• Other study ID #: N201909051
• Secondary ID: MOST-108-2321-B-
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: March 2021
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare	New Taipei City
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Taipei Municipal Wanfang Hospital - Taipei Medical University	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Taipei Medical University	Ministry of Science and Technology, R.O.C (Taiwan), National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)