Clinical trial NCT05981989: Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
Official title: Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)
timeFrame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
measure: Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
timeFrame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Secondary outcomes:
measure: Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
measure: Change in spasticity as measured by the Modified Ashworth Scale (MAS)
timeFrame: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Study officials:
affiliation: Hualien Tzu Chi General Hospital
name: Sheng-Tzung Tsai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: