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

NCT ID: NCT05433064

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural Stimulator

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.

Group Type EXPERIMENTAL

Epidural Stimulator

Intervention Type 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.

Interventions

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Epidural Stimulator

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.

Intervention Type DEVICE

Other Intervention Names

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Abbott Lead-3219

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheng-Tzung Tsai, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hualien Tzu Chi General Hospital

Locations

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Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Tzung Tsai, M.D., Ph.D.

Role: CONTACT

+886-3-856-1825 ext. 13054

Yu-Chen Chen

Role: CONTACT

+886-3-856-1825 ext. 13054

Facility Contacts

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Sheng-Tzung Tsai

Role: primary

+886-3-856-1825 ext. 13054

Yu-Chen Chen

Role: backup

+886-3-856-1825

References

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Wu MY, Chen LH, Yang CH, Wu CC, Huang XL, Yan LC, Lin SZ, Wang PK, Lee CH, Chen YC, Tsai ST. Synergistic effect of epidural electrical stimulation and exoskeleton walk training on dynamic balance for participants with spinal cord injury. J Spinal Cord Med. 2025 Oct 24:1-10. doi: 10.1080/10790268.2025.2574134. Online ahead of print.

Reference Type DERIVED
PMID: 41134059 (View on PubMed)

Chen YC, Huang XL, Cheng HY, Wu CC, Wu MY, Yan LC, Chen SY, Tsai ST, Lin SZ. Role of Epidural Electrode Stimulation in Three Patients with Incomplete AIS D Spinal Cord Injury. Biomedicines. 2025 Jan 10;13(1):155. doi: 10.3390/biomedicines13010155.

Reference Type DERIVED
PMID: 39857740 (View on PubMed)

Other Identifiers

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TCMF-EP 110-02(111)

Identifier Type: -

Identifier Source: org_study_id

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