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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981989
• Other study ID #: IRB112-125-A
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Buddhist Tzu Chi General Hospital
• Contact: Sheng-Tzung Tsai, M.D., Ph.D.
• Phone: +886-3-856-1825
• Email: flydream.tsai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is main assesses motor functioning and sensation in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and plan and assess treatment. The upper extremity motor function score ranges from 0 to 66.	Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Primary	Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)	Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.	Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Secondary	Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)	The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". , The higher the score, the better the quality of life	Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Secondary	Change in spasticity as measured by the Modified Ashworth Scale (MAS)	Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity.	Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation