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

Buddhist Tzu Chi General Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Device: Epidural electrical stimulation (EES)

Study type: Interventional

Funder types: Other

Identifiers

NCT05981989

IRB112-125-A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Epidural electrical stimulation (EES)

Experimental group

Description:

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.

Treatment:

Device: Epidural electrical stimulation (EES)