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NCT Number: NCT05981989

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

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The purpose of this study is to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, Participants will undergo a structured physical rehabilitation program and electrical stimulation. Researchers will quantify the motor potentials in the arm and hand muscles generated by EES of the cervical spinal cord, tune optimal stimulation parameters to induced arm and hand movement, and assess participant motor function of the upper limb with standard clinical tests and simple motor tasks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". , The higher the score, the better the quality of life

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

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

    Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+886-3-856-1825 ext. 13054

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

CONTACT

[email protected]

+886-3-856-1825 ext. 13054

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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