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

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

    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 groups

12 Participants
are divided into 1 treatment group
Group A: Epidural StimulatorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-Meter Time Up and Go (6TUG)

To evaluate gait for subjects who can walk by assistive device or independently.

Time frame
To measure assessing change between pre-implant and every 3 months until 24 months.
2

Assessment of volitional movement of lower limbs using electromyographic analysis

Average of 6-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

Trunk stability measurement (trunk control assessment)

To assess the sitting and walking dynamic balance by displacing the center of pressure (CoP) from the force plate and the trunk accelerations with a tri-axial accelerometer. The experiment includes sitting and walking.pressure (CoP) from the force plate and the trunk accelerations with tri-axial accelerometer.

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

Secondary outcomes

1

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

Time frame
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
2

Change in spasticity as measured by the Modified Ashworth Scale (MAS)

It is mainly used to assess muscle spasm (spasticity). 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
3

Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score

The American Spinal Injury Association (ASIA) Standard Neurological Classification of Spinal Cord Injury is a standard method of assessing the neurological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury.

Time frame
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
4

Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS)

It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.a 14-item scale.

Time frame
Baseline; 7 months after implant

Other outcomes

Sponsors and contacts

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