High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation

Taipei Medical University Hospital48 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. We developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, we will preliminarily examine the effects and safety of the HD-tCES on lower extremity in patients with stroke. We expect that the HD-tCES combined with the lower 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

DOUBLE

Enrollment

Conditions

Stroke

Interventions

The high definition transcranial electrical stimulation was applied using a 1\*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). 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-tCESDEVICE

The high definition transcranial electrical stimulation was applied using a 1\*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). 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. With a diagnosis of stroke. 2. Age ≥ 20 years. 3. Hemiplegia, Brunnstrom stage III-V. 4. 6 months to 5 years after stroke. 5. Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale. 6. Ability to walk for 10 min non-stop with no gait aids or ability to walk 20 m with supervision or slight assistance. Exclusion Criteria: 1. Intolerance to electrical stimulation. 2. Contracture on lower extremities, and limitation in joint range of motion. 3. Severe spasticity. 4. Ossification or inflammation in muscle tissue. 5. A history of arrhythmia. 6. Implantable medical electronic devices (e.g., like pacemaker). 7. Metal implants in the head or neck. 8. Wounds on the skin of head. 9. A history of brain surgery or severe brain trauma. 10. Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder). 11. A history of seizure or other brain pathology. 12. Drug or alcohol abuse. 13. Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD) 14. Undergoing other non-invasive brain stimulation. 15. Intra-cerebral lesions (such as brain tumors, arteriovenous tumors). 16. History of encephalitis or meningitis. 17. Stroke lesion in cerebellum or brainstem. 18. Leg amputation. 19. Sleep deprivation. 20. Severe or recent heart disease. 21. Subjects who use drugs that may lower the seizure threshold. 22. Pregnant or breastfeeding women.

Locations (3)

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

Taipei Municipal Wanfang Hospital - Taipei Medical University

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in the Fugl-Meyer Assessment lower extremity scale (FMA-LE) after intervention

The FMA-LE assesses motor functioning of lower extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-LE is 34, and a higher score indicates that the patient has better movement ability.