Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation

NCT07139496 | Recruiting

• 1 other identifier: UW 25-294
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord stimulation (SCS) has been shown in previous studies to be capable of restoring motor and autonomic function in patients with chronic complete spinal cord injury (SCI). Clinical studies have demonstrated that SCS enables activation of previously paralyzed muscles, leading to functional improvements in patients in the chronic stage of paralysis through the delivery of activity-based interventions. For most previous studies on SCS in SCI, stimulation was invariably applied to lumbrosacral plexus only. In this study, after signing the consent form, the patient will be assigned for standard surgery with additional implant of the spinal cord stimulator. The investigators propose to conduct the SCS with three phases. For the first phase, SCS over lumbrosacral spinal cord will be activated for 3 months with appropriate stimulation of lower limb muscles for walking together with physiotherapy of individual muscle groups for walking. For the second phase, SCS over lumbrosacral spinal cord will be stopped. SCS over the injury site will be activated for 3 months with appropriate stimulation of lower limb muscles. For the third phase, SCS over both lumbrosacral spinal cord and injury site of spinal cord will be activated for another 3 months with appropriate stimulation of lower limb muscles.

Conditions

Spinal Cord Injuries (SCI)

Keywords

Injury-site; Lumbosacral Epidural Stimulation; Spinal Cord Injury; Spinal cord stimulation

Outcome Measures

Primary Outcomes (6)

• Assisted/independent standing or stepping (A/I) [Time Frame: Changes from baseline to the third phase of the intervention]

  Assisted/independent standing or stepping of participants will be recorded, with 0 = unable, 1 = maximal assistance, 2 = moderate assistance, 3 = independent with device, 4 = fully independent.

  From baseline to three months after the third phase of the intervention.

• Gait analysis (GA) [Time Frame: Changes from baseline to the third phase of the intervention]

  The participants' hip, knee range of motion will be recorded. The walking speed will also be recorded.

  From baseline to three months after the third phase of the intervention.

• Overground walking (OGW) [Time Frame: Changes from baseline to the third phase of the intervention]

  The speed, time and distance for the participants' overground walking will be recorded.

  From baseline to three months after the third phase of the intervention.

• Treadmill stepping/ walking (TSW) [Time Frame: Changes from baseline to the third phase of the intervention]

  The maximum tolerated speed (m/s) and duration (minutes) for treadmill stepping/walking will be recorded.

  From baseline to three months after the third phase of the intervention.

• Walking Index for Spinal Cord Injury Scale (WISCI 2) [Time Frame: Changes from baseline to the third phase of the intervention]

  A score from 0 to 20 will be recorded for WISCI II. Level 0: "patient is unable to stand and/or participate in assisted walking" to level 20: "ambulates with no devices, no braces and no physical assistance, 10 meters".

  From baseline to three months after the third phase of the intervention.

• Sensory assessments of the lower limbs [Time Frame: Changes from baseline to the third phase of the intervention]

  The sensory changes of the participants will be recorded with 'absent', reduced' or 'present'.

  From baseline to three months after the third phase of the intervention.

Secondary Outcomes (4)

• Pain Intensity [Time Frame: Changes from baseline to the third phase of the intervention]

  From baseline to three months after the third phase of the intervention.

• Quality of Life [Time Frame: Changes from baseline to the third phase of the intervention]

  From baseline to three months after the third phase of the intervention.

• Psychological Symptoms [Time Frame: Changes from baseline to the third phase of the intervention]

  From baseline to three months after the third phase of the intervention.

• Presence of neuropathic pain [Time Frame: Changes from baseline to the third phase of the intervention]

  From baseline to three months after the third phase of the intervention.

Study Arms (1)

Spinal Cord Stimulator

EXPERIMENTAL

After signing the consent form, the patient will be assigned for standard surgery with additional implant of the spinal cord stimulator. Two percutaneous SCS leads will be placed at the level of SCI. These leads were anchored and were tunneled to subcutaneous space in posterior iliac crest and were connected to impulse generator. Another two percutaneous SCS leads will be placed over the lumbrosacral spinal cord. Intraoperative neurological monitoring will be performed. The aim is to determine spinal segmental mapping and to elicit evoked action potentials with contraction of muscles related to locomotor function of the lower limbs. These leads were anchored and were tunneled to subcutaneous space in posterior iliac crest and were connected to impulse generator.

Device: Spinal Cord Stimulator

Interventions

Spinal Cord Stimulator DEVICE

After the implantation of the spinal cord stimulator, the study will begin with 3 phases: For the first phase, SCS over lumbrosacral spinal cord will be activated for 3 months with appropriate stimulation of lower limb muscles for walking. For the second phase, SCS over lumbrosacral spinal cord will be stopped. SCS over the injury site will be activated for 3 months with appropriate stimulation of lower limb muscles for walking. For the third phase, SCS over both lumbrosacral spinal cord and injury site of spinal cord will be activated for another 3 months with appropriate stimulation of lower limb muscles for walking During all the phrases, physiotherapy of individual muscle groups for walking will be arranged. Exoskeleton training will also be arranged for 4 to 5 hours per week.

Spinal Cord Stimulator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist (ASA) status I-III
• Age 18-70 years old
• Patients with SCI more than 2 years
• Traumatic or atraumatic spinal cord injury
• American Spinal Injury Association (ASIA) Impairment Scale A and B
• Have previous MRI to document extent of spinal cord injury before recruitment

You may not qualify if:

• Chronic opioid user
• Presence of chronic pain condition (pain duration over 3 months)
• Alcohol or substance abuse
• active and unaddressed psychiatric diseases

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Timmy CW Chan, MBBS

CONTACT

(852)22555679; timmychancw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Anaesthesia, Pain & Perioperative Medicine

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)