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Recruiting NCT05981989

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epidural electrical stimulation (EES).
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • Device 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.

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Identifiers

NCT: NCT05981989 · IRB112-125-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗