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

NCT ID: NCT05981989

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural electrical stimulation (EES)

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.

Group Type EXPERIMENTAL

Epidural electrical stimulation (EES)

Intervention Type 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.

Interventions

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Epidural electrical stimulation (EES)

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Hualien Tzu Chi General Hospital

Locations

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Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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

Role: CONTACT

+886-3-856-1825 ext. 13054

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

Role: CONTACT

+886-3-856-1825 ext. 13054

Facility Contacts

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

Role: primary

+886-3-856-1825 ext. 13054

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

Role: backup

+886-3-856-1825 ext. 13054

Other Identifiers

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IRB112-125-A

Identifier Type: -

Identifier Source: org_study_id

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