Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain

NCT05981989 | Recruiting FDA Device

• 1 other identifier: IRB112-125-A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the upper limbs in people with hemiplegia following a stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is main assesses motor functioning and sensation in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and plan and assess treatment. The upper extremity motor function score ranges from 0 to 66.

  Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation

• Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)

  Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.

  Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation

Secondary Outcomes (2)

• Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)

  Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation

• Change in spasticity as measured by the Modified Ashworth Scale (MAS)

  Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation

Study Arms (1)

Epidural electrical stimulation (EES)

EXPERIMENTAL

Subjects will be implanted with 16-electrode epidural array in the C6-T1 area of the spinal cord. After surgery, subjects will undergo a structured program of physical rehabilitation and electrical stimulation.

Device: Epidural electrical stimulation (EES)

Interventions

Epidural electrical stimulation (EES) DEVICE

Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation.

Epidural electrical stimulation (EES)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 20 and 70 years of age
• First-ever clinical manifest stroke
• Right or left hemiparesis
• Scores higher than 7 and lower than 45 on the Fugl-Meyer scale.
• Expected will undergo spinal cord stimulation surgery.
• Able to comply with procedures and follow up.
• Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities.

You may not qualify if:

• Pregnancy or breast feeding.
• Have Major depressive disorder.
• Had a mental illness within one year or been treated in the past.
• Have significant cognitive impairment (MMSE\<24) or serious disease that could affect the ability to participate in study activities.
• Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
• Receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to or throughout the duration of the study.
• Unable to read and/or comprehend the consent form.
• Have concerns about this trial and do not sign consent.
• Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Sheng-Tzung Tsai, M.D., Ph.D.

  Hualien Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Tzung Tsai, M.D., Ph.D.

CONTACT

+886-3-856-1825; flydream.tsai@gmail.com

Yu-Chen Chen, M.D., Ph.D.

CONTACT

+886-3-856-1825; spring810569@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

TW (1)