Spinal Cord Injuries (SCI)NCT07139496
Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation
A study testing Spinal Cord Stimulator in people with Spinal Cord Injuries (SCI), run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Spinal Cord Stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic opioid user
- Presence of chronic pain condition (pain duration over 3 months)
- Alcohol or substance abuse
- active and unaddressed psychiatric diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Timmy Chi Wing Chan, (852) 2255 5679, chancw06@ha.org.hk
About this study
Official title: Combined Injury-site & Lumbosacral Epidural Stimulation for Spinal Cord Injury - a Pilot Study.
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.
Read the 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)
- Being tested
- Spinal Cord Stimulator
- Keywords
- Injury-site, Lumbosacral Epidural Stimulation, Spinal Cord Injury, Spinal cord stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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'.
Measured: 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]
NRS pain scores with movement will be recorded (NRS scale 0-10, where 0 is no pain, and 10 is the worst possible pain)
Measured: 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]
A SF36 questionnaire with scores range from 0 to 100 for eight domains will be recorded, with a higher score defining a more favorable health state. The eight domains include: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Measured: 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]
The Depression and Anxiety Symptom Stress Scale (DASS) of participants will be recorded. A score range from 0 to 42 in depression, anxiety and stress will be recorded with a higher score meaning a more severe psychological symptom.
Measured: 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]
A score of 3 or higher from an Identification Pain Questionnaire will be used to indicate the likely presence of neuropathic pain.
Measured: From baseline to three months after the third phase of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Chi-Wing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139496
- Sponsor's protocol ID
- UW 25-294
- Status last verified
- Nov 2025
- First submitted
- 7 Jul 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Injury-site & Lumbosacral Epidural Stimulation for Spinal Cord Injury - a Pilot Study.
- ClinicalTrials.gov ID
- NCT07139496
- Acronym / sponsor ID
- UW 25-294
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- Injury-site, Lumbosacral Epidural Stimulation, Spinal Cord Injury, Spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulator | Experimental | Device: Spinal Cord StimulatorAfter 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Chronic opioid user
- Presence of chronic pain condition (pain duration over 3 months)
- Alcohol or substance abuse
- active and unaddressed psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulatorAfter 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. | Device | Spinal Cord Stimulator |
Primary outcome
Assisted/independent standing or stepping (A/I) [Time Frame: Changes from baseline to the third phase of the intervention]
Time frame: From baseline to three months after 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.
Gait analysis (GA) [Time Frame: Changes from baseline to the third phase of the intervention]
Time frame: From baseline to three months after the third phase of the intervention.
The participants' hip, knee range of motion will be recorded. The walking speed will also be recorded.
Overground walking (OGW) [Time Frame: Changes from baseline to the third phase of the intervention]
Time frame: From baseline to three months after the third phase of the intervention.
The speed, time and distance for the participants' overground walking will be recorded.
Treadmill stepping/ walking (TSW) [Time Frame: Changes from baseline to the third phase of the intervention]
Time frame: From baseline to three months after the third phase of the intervention.
The maximum tolerated speed (m/s) and duration (minutes) for treadmill stepping/walking will be recorded.
Walking Index for Spinal Cord Injury Scale (WISCI 2) [Time Frame: Changes from baseline to the third phase of the intervention]
Time frame: From baseline to three months after 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".
Sensory assessments of the lower limbs [Time Frame: Changes from baseline to the third phase of the intervention]
Time frame: From baseline to three months after the third phase of the intervention.
The sensory changes of the participants will be recorded with 'absent', reduced' or 'present'.
4 secondary outcomes
Pain Intensity [Time Frame: Changes from baseline to the third phase of the intervention]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: From baseline to three months after the third phase of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulator in people with Spinal Cord Injuries (SCI), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timmy CW Chan, MBBS ((852)22555679, timmychancw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisted/independent standing or stepping (A/I) [Time Frame: Changes from baseline to the third phase of the intervention] (time frame: From baseline to three months after the third phase of the intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.