Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation

NCT ID: NCT07139496

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-03-01

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.

Detailed Description

Spinal cord injury (SCI) causes damage to motor, sensory, and autonomic function below the level of injury. This can have a huge impact on the daily function of the patients, with devastating effects on their quality of life, especially those with paralysis. Surgical treatment including decompression surgery is an option to improve the neurological outcome of these patients if the paralysis or limb weakness were surgically correctable. However, even with surgical treatment, there are still many patients with residual neurological deficits, which may greatly impair their activities of daily living. Patients with post-SCI may also develop chronic debilitating pain, because of neurophysiological changes in the somatosensory system.

Spinal cord stimulation (SCS) has increasingly been used as a potential method of improving motor function and for pain relief in patients with spinal cord injury. SCS is a well-established therapeutic treatment with robust evidence, in the management of chronic neuropathic and ischaemic pain syndromes, including persistent back pain after surgery, complex regional pain syndrome, and chronic ischemic pain condition. Its proposed mechanism of analgesic effects includes the gate control theory of pain, and enhancement of GABAergic systems of dorsal horn cells by stimulating their dendrites. Currently, there is a lack of mechanistic studies of SCS for SCI pain and its effectiveness is not well established.

SCS has been shown in previous studies to be capable of restoring motor and autonomic function in patients with chronic complete spinal cord injury. 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. The proposed mechanism for the effects of relate to the increased excitability of the central pattern generators (CPG) and enhance tonic and rhythmic motor patterns in persons after SCI and results in the activation of lower extremity muscles for standing and stepping with and without assistive devices. It was also shown that SCS in combination with locomotor training provides sensorimotor training of the spinal circuitry and facilitates standing stepping to enhance neuroplasticity.

In this study the investigators hypothesize that the application of SCS to the injury site can provide a neuromodulatory effect to the recovering neurons, allowing for improved neurological function caudal to the injury site. The investigators propose to conduct a clinical trial to determine whether the application of SCS to both injury site and lumbrosacral spinal cord, instead of SCS over lumbrosacral spinal cord alone, can further improve motor function in patients with motor-complete subacute and chronic spinal cord injury. The investigators will also assess longer term secondary outcomes including lower limb functional scores, chronic pain, and health related quality of life.

Conditions

Spinal Cord Injuries (SCI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spinal Cord Stimulator

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.

Group Type: EXPERIMENTAL

Spinal Cord Stimulator

Intervention Type: 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.

Interventions

Spinal Cord Stimulator

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. American Society of Anesthesiologist (ASA) status I-III

2. Age 18-70 years old

3. Patients with SCI more than 2 years

4. Traumatic or atraumatic spinal cord injury

5. American Spinal Injury Association (ASIA) Impairment Scale A and B

6. Have previous MRI to document extent of spinal cord injury before recruitment

Exclusion Criteria

1. Chronic opioid user

2. Presence of chronic pain condition (pain duration over 3 months)

3. Alcohol or substance abuse

4. active and unaddressed psychiatric diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chan Chi-Wing

Consultant, Department of Anaesthesia, Pain & Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Timmy CW Chan, MBBS

Role: CONTACT

timmychancw@gmail.com

(852)22555679

Facility Contacts

Timmy Chi Wing Chan

Role: primary

chancw06@ha.org.hk

(852) 2255 5679

Other Identifiers

UW 25-294

Identifier Type: -

Identifier Source: org_study_id