Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain

Buddhist Tzu Chi General Hospital

Status: Enrolling

Conditions: Spinal Cord Injury

Treatments: Device: Epidural Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT05433064

TCMF-EP 110-02(111)

Details and patient eligibility

About

The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

Full description

The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote lower limb activity so that SCI patients can restore the ability to stand and walk under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore lower limb mobility and improve quality of life.

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SCI ASIA: A, B, C,D
• Between 20 and 70 year of age
• >1 year post SCI
• Complete or incomplete spinal cord injury.
• Expected will undergo spinal cord stimulation surgery.
• Continued rehabilitation after surgery for spinal cord injury.
• Able to comply with procedures and follow up.
• Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in lower extremity rehabilitation or testing activities

Exclusion criteria

• Have significant cognitive impairment (MMSE<24).
• Had a mental illness within one year or been treated in the past.
• Have Major depressive disorder.
• Active cancer diagnosis.
• Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.
• Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
• Unable to read and/or comprehend the consent form.
• Have concerns about this trial and do not sign consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Epidural Stimulator

Experimental group

Description:

Subjects will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord. After 2 weeks recovery,patients will undergo a structured program of physical rehabilitation and electrical stimulation.

Treatment:

Device: Epidural Stimulator