Spinal Cord Injury at T1-T12 LevelNCT04894734
Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
A study testing EES on and EES off in people with Spinal Cord Injury at T1-T12 Level and Traumatic Thoracic Spinal Cord Contusion, run by Nandan Lad, M.D., Ph.D. at 1 site in United States.
Trial summary
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury at T1-T12 Level, Traumatic Thoracic Spinal Cord Contusion, Thoracic Spinal Cord Trauma
- What is being tested?
- EES on and EES off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2021to 30 Jun 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):
- Traumatic, thoracic SCI
- Chronic neuropathic pain (i.e., Pain >3 for > 3 months)
- Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
- 18-80 years of age
- Medically stable enough to undergo surgical implantation of an SCS / participate in rehabilitation regimens
Who cannot join
- Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement):
- Complete cord transection
- Persistent spinal instability or other injury preventing ability to participate
- Active infection
- Comorbid psychosis or psychotic disorder
- Untreated, clinically significant depression
Show all 10Show fewer
- Active drug or alcohol abuse
- Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test
- Patients without symptoms of neuropathic pain >3/10 for > 3 months
- Patient deemed not medically stable for surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Systems
Durham, North Carolina, 27710
About this study
Official title: The Feasibility of Epidural Electrical Stimulation (EES) for Improving Pain and Rehabilitation Outcomes in Patients With Spinal Cord Injury (SCI)
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 24 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy.
Participating subjects will be allocated to one of two treatment groups:
Read more
- Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation.
- Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation).
For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm.
At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 24 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
Read the detailed description
This study is a prospective, single center study. Data will be collected at baseline, time of procedure (trial and permanent), trial phase, and at 1, 3, 6, 12, 18, and 24 months post-implantation.
The primary objective of this study is to to determine if neuromodulation can be used to augment pain relief and rehabilitation in spinal cord injury (SCI) in a real-world population while further characterizing neurophysiological measures and clinical outcomes.
The following data will be collected:
- Medical history and demographics
- Procedure characteristics
- Medications
- Visual Analog Scale (VAS) for pain intensity Guy/Farrar Patient Global Impression of Change (PGIC) scale ASIA motor and sensory scores and impairment grade
- QoL survey (PROMIS 29)
- Electromyography (EMG) / Nerve Conduction Studies (NCS)
- Spinal Cord Independence Measure (SCIM) survey
- Bladder control using standard clinical urodynamic studies
- For sleep, self-reported quality and average hours per night will be collected in a diary
- Programming parameters and characteristics
- Safety events (adverse events, device deficiencies, protocol deviations)
The outcome variables of interest will be collected and assessed across study visits. No pre-planned formal statistical hypothesis tests will be performed. Multivariable regression modeling and descriptive statistics will be utilized.
- Conditions
- Spinal Cord Injury at T1-T12 Level, Traumatic Thoracic Spinal Cord Contusion, Thoracic Spinal Cord Trauma, Traumatic Thoracic Spinal Cord Laceration, Post-Traumatic Thoracic Myelopathy, Traumatic Thoracic Spinal Cord Myelopathy
- Being tested
- EES on, EES off
- Keywords
- Spinal Cord Injury
- 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.
EES onDevice
Also called SCS (Spinal Cord Stimulation)
Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
EES offDevice
Also called SCS
Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
| Study group | Role | What they receive |
|---|---|---|
| EES on | Experimental | Patients will undergo epidural electrical stimulation (EES) and be allocated 1:1 to EES on.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. Receives: Device: EES on |
| EES off | Placebo comparator | Patients will undergo epidural electrical stimulation (EES) and allocated 1:1 to EES off.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. Those in the EES off category will have their EES turned on at the 9-month time point. Receives: Device: EES off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Multidimensional Pain Inventory (MPI)-SCI average activity score
The MPI-SCI consists of twelve 7-point subscales in three sections: (1) pain impact, (2) responses by significant others, and (3) activity. Our primary outcome is the average score of the 4 pain subscales (household activities, activities away from home, social activities, and outdoor work) for pain and consequences of SCI. These 4 scales are commonly used to create a single general activity scale. To define the degree to which pain and other consequences of injury reduced participation in a specific activity, 2 additional validated items will be used in section 3: (1) "Pain has reduced my participation in this activity," and (2) "Other consequences of SCI have reduced my participation in this activity." The response range from 0 (not at all) to 6 (extremely).
Measured: Baseline, 3 months
Secondary outcomes (9)
Change in pain as measured by Visual Analog Scales (VAS)
Validated assessment of pain severity (0-10 scale), 0 being no pain to 10 being the worst pain, in the past 7 days.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in Quality of Life (QOL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29
The PROMIS-29 is a generic health-related quality of life survey that assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The seven domains cover the most relevant areas of self-reported health for the greatest majority of people with chronic illness.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in the overall improvement as measured by Guy/Farrar Patient Global Impression of Change (PGIC) scale
The self-report measure PGIC reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score
ASIA Upper Extremity and Lower Extremity Motor Score (UEMS \& LEMS), combine to give Total ASIA Motor Score.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by the ASIA impairment grades
The ASIA Impairment Scale (AIS), based on the Frankel scale, is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI. It identifies sensory and motor levels indicative of the highest spinal level demonstrating "unimpaired" function. Preservation of function in the sacral segments (S4-S5) is a key for determining the AIS grade. AIS scores are considered essential when classifying persons with SCI as to their neurological status.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in independence of activities of daily living (ADLs) as measured by the Spinal Cord Independence Measure (SCIM) survey
SCIM Disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently. Three versions of the SCIM (I-III) have been consecutively developed and assess three areas: 1) self-care (feeding, grooming, bathing, and dressing); 2) respiration and sphincter management; 3) mobility (bed and transfers and indoor/outdoor). The item scores are weighted related to the assumed clinical relevance.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in bladder control using urodynamics
A urodynamic test is used to measure nerve and muscle function, pressure around and in the bladder, flow rates, and other factors. These tests look at how well the bladder, sphincters, and urethra are storing and releasing urine. All measures are combined to give one overall score of bladder control.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS MEPs)
To evaluate the connectivity of descending motor signals passing through the injury, TMS MEPs are recorded bilaterally over the rectus femoris (RF), vastus lateralis (VL), medial hamstring (MH), tibialis anterior (TA), medial gastrocnemius (MG), and soleus (SOL) muscles using skin surface EMG at a sampling rate of 4 kHz.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by EMG
EMGs will be recorded using surface or needle electrodes placed over/in the following muscles: bilateral gluteus maximus, bilateral rectus femoris, bilateral vastus lateralis, bilateral medial hamstrings, bilateral anterior tibialis and bilateral gastrocnemius. When clinically appropriate, bilateral extensor carpi radialis, bilateral biceps, and bilateral abdominal muscles will be used as controls.
Measured: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start30 Dec 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury at T1-T12 LevelStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nandan Lad, M.D., Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nandan Lad, M.D., Ph.D., Duke University
- Investigators
- Shivanand Lad, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894734
- Sponsor's protocol ID
- Pro00106738
- Status last verified
- Jun 2026
- First submitted
- 7 May 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Epidural Electrical Stimulation (EES) for Improving Pain and Rehabilitation Outcomes in Patients With Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT04894734
- Acronym / sponsor ID
- Pro00106738
- Conditions
- Spinal Cord Injury at T1-T12 Level, Traumatic Thoracic Spinal Cord Contusion, Thoracic Spinal Cord Trauma, Traumatic Thoracic Spinal Cord Laceration, Post-Traumatic Thoracic Myelopathy, Traumatic Thoracic Spinal Cord Myelopathy
- Keywords
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nandan Lad, M.D., Ph.D.University, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 May 2021 (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.
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 24 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy.
Participating subjects will be allocated to one of two treatment groups:
- Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation.
- Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation).
For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm.
At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 24 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
Detailed description
This study is a prospective, single center study. Data will be collected at baseline, time of procedure (trial and permanent), trial phase, and at 1, 3, 6, 12, 18, and 24 months post-implantation.
The primary objective of this study is to to determine if neuromodulation can be used to augment pain relief and rehabilitation in spinal cord injury (SCI) in a real-world population while further characterizing neurophysiological measures and clinical outcomes.
The following data will be collected:
- Medical history and demographics
- Procedure characteristics
- Medications
- Visual Analog Scale (VAS) for pain intensity Guy/Farrar Patient Global Impression of Change (PGIC) scale ASIA motor and sensory scores and impairment grade
- QoL survey (PROMIS 29)
- Electromyography (EMG) / Nerve Conduction Studies (NCS)
- Spinal Cord Independence Measure (SCIM) survey
- Bladder control using standard clinical urodynamic studies
- For sleep, self-reported quality and average hours per night will be collected in a diary
- Programming parameters and characteristics
- Safety events (adverse events, device deficiencies, protocol deviations)
The outcome variables of interest will be collected and assessed across study visits. No pre-planned formal statistical hypothesis tests will be performed. Multivariable regression modeling and descriptive statistics will be utilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EES on | Experimental | Device: EES onPatients will undergo epidural electrical stimulation (EES) and be allocated 1:1 to EES on.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. |
| EES off | Placebo comparator | Device: EES offPatients will undergo epidural electrical stimulation (EES) and allocated 1:1 to EES off.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. Those in the EES off category will have their EES turned on at the 9-month time point. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):
- Traumatic, thoracic SCI
- Chronic neuropathic pain (i.e., Pain >3 for > 3 months)
- Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
- 18-80 years of age
Key exclusion criteria (10 listed)
- Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement):
- Complete cord transection
- Persistent spinal instability or other injury preventing ability to participate
- Active infection
- Comorbid psychosis or psychotic disorder
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 |
|---|---|---|
| EES onAlso: SCS (Spinal Cord Stimulation)Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb. | Device | EES on |
| EES offAlso: SCSEpidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb. | Device | EES off |
Primary outcome
Change in Multidimensional Pain Inventory (MPI)-SCI average activity score
Time frame: Baseline, 3 months
The MPI-SCI consists of twelve 7-point subscales in three sections: (1) pain impact, (2) responses by significant others, and (3) activity. Our primary outcome is the average score of the 4 pain subscales (household activities, activities away from home, social activities, and outdoor work) for pain and consequences of SCI. These 4 scales are commonly used to create a single general activity scale. To define the degree to which pain and other consequences of injury reduced participation in a specific activity, 2 additional validated items will be used in section 3: (1) "Pain has reduced my participation in this activity," and (2) "Other consequences of SCI have reduced my participation in this activity." The response range from 0 (not at all) to 6 (extremely).
9 secondary outcomes
Change in pain as measured by Visual Analog Scales (VAS)
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in Quality of Life (QOL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in the overall improvement as measured by Guy/Farrar Patient Global Impression of Change (PGIC) scale
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by the ASIA impairment grades
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in independence of activities of daily living (ADLs) as measured by the Spinal Cord Independence Measure (SCIM) survey
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in bladder control using urodynamics
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS MEPs)
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
Change in motor recovery as measured by EMG
Time frame: Baseline, and then months 1, 3, 6, 9, 12, 18 and 24
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 4 Jun 2026.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Shivanand Lad, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EES on and EES off in people with Spinal Cord Injury at T1-T12 Level and Traumatic Thoracic Spinal Cord Contusion, run by Nandan Lad, M.D., Ph.D. at 1 site in United States.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Multidimensional Pain Inventory (MPI)-SCI average activity score (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894734, which also lists 1 linked publication.
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 4 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.