High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Taipei Medical University24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Sham HD-tCESDEVICE

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (3)

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, Taiwan

Outcomes

Primary Outcomes

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.