High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation

NCT04515121 | Unknown

• 1 other identifier: N202004091
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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. 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.

Conditions

Stroke

Keywords

Stroke, Transcranial electrical stimulation, Lower-limb rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)

Secondary Outcomes (6)

• Change from baseline in the Berg Balance Scale (BBS) 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)

• Change from baseline in the Timed Up and Go Test (TUG) 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)

• Change from baseline in the Gait Evaluation 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)

• 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)

• Change from baseline motor evoked potential (MEP) 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)

Study Arms (2)

HD-tCES & lower limb rehabilitation

EXPERIMENTAL

The experiment group will receive HD-tCES combined with lower limb rehabilitation of affected side.

Device: HD-tCES; Other: Lower limb rehabilitation

Sham HD-tCES & lower limb rehabilitation

SHAM COMPARATOR

The sham control group will receive sham HD-tCES combined with lower limb rehabilitation of affected side.

Device: Sham HD-tCES; Other: Lower limb rehabilitation

Interventions

HD-tCES DEVICE

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.

HD-tCES & lower limb rehabilitation

Sham HD-tCES DEVICE

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.

Sham HD-tCES & lower limb rehabilitation

Lower limb rehabilitation OTHER

Lower limb rehabilitation programs will be selected and graded in accordance with each patient's lower limb function and specific aims of activities of daily living. Lower limb rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks.

HD-tCES & lower limb rehabilitation; Sham HD-tCES & lower limb rehabilitation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With a diagnosis of stroke.
• Age ≥ 20 years.
• Hemiplegia, Brunnstrom stage III-V.
• months to 5 years after stroke.
• Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
• Ability to walk for 10 min non-stop with no gait aids or ability to walk 20 m with supervision or slight assistance.

You may not qualify if:

• Intolerance to electrical stimulation.
• Contracture on lower extremities, and limitation in joint range of motion.
• Severe spasticity.
• Ossification or inflammation in muscle tissue.
• A history of arrhythmia.
• Implantable medical electronic devices (e.g., like pacemaker).
• Metal implants in the head or neck.
• Wounds on the skin of head.
• A history of brain surgery or severe brain trauma.
• Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
• A history of seizure or other brain pathology.
• Drug or alcohol abuse.
• Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
• Undergoing other non-invasive brain stimulation.
• Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (3)

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

New Taipei City, 235, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Taipei Municipal Wanfang Hospital - Taipei Medical University

Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chien-Hung Lai, PhD

CONTACT

+886-2-27372181; chlai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: August 20, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)