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

Last updated: August 18, 2024
Sponsor: Buddhist Tzu Chi General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Epidural electrical stimulation (EES)

Clinical Study ID

NCT05981989
IRB112-125-A
  • Ages 20-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 wouldcontraindicate participation in upper extremity rehabilitation or testingactivities.

Exclusion

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 affectthe ability to participate in study activities.

  • Cardiovascular or musculoskeletal disease or injury that would prevent fullparticipation in physical therapy intervention.

  • Receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to orthroughout 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 toosevere to participate in study activities.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Epidural electrical stimulation (EES)
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

    Hualien City, 970
    Taiwan

    Active - Recruiting

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