Health Trialsby

Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement

ConditionSpinal Cord Injuries

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-70

SponsorBuddhist Tzu Chi General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

SCI ASIA: A, B, C,D

Between 20 and 70 year of age

>1 year post SCI

Complete or incomplete spinal cord injury.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Epidural Stimulator
Device
Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Epidural StimulatorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Electroencephalography and Electromyography

To measure activity in the brain

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

2

Electromyographic analysis

Average of 5-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

3

Single transcranial magnetic stimulation

To evaluate the function of corticospinal tract nerve conduction

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

4

Motion Analysis

To evaluate the angles that can be achieved at each joint of the upper limbs

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

Secondary outcomes

1

American Spinal Injury Association (ASIA-2019) Impairment Scale

To measure and record disease history In simpler terms, it's a 5-point scale that categorizes individuals from "A" (complete spinal cord injury) to "E" (normal sensory and motor function), with each letter representing a different level of injury severity: A: Complete spinal cord injury. B: Sensory incomplete injury. C: Motor incomplete injury. D: Motor incomplete injury. E: Normal sensory and motor function.

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

2

Modified Ashworth scale

To measure the increase of muscle tone,it uses a 6-point system. Scores range from 0 to 4. Lower scores indicate normal muscle tone, while higher scores indicate spasticity or increased resistance to passive movement.

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

3

Barthel Index

To measure performance in activities of daily living

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

4

World Health Organization Quality of Life Brief Version

A brief version scale of World Health Organization Quality-of-Life scale

Time frame

To measure assessing change between pre-implant and every 3 months until 24 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Buddhist Tzu Chi General Hospital

Lead sponsor

Source ClinicalTrials.gov