Spinal Cord InjuriesRISES-TNCT05669508
Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity
A study testing RISES-T System and Occupational/Physical Therapy in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases
- What is being tested?
- RISES-T System and Occupational/Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 31 Dec 2026
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has a non-progressive or central cord spinal cord injury from C2-T10 inclusive
- Has American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
- Can participate in physical and occupational therapy rehabilitation programs
- Is at minimum 12 months post- spinal cord injury
- Can provide informed consent
- Has adequate caregiver support to facilitate participation in study
Who cannot join
- Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by the Investigator)
- Has diffuse lower motor neuron injury rendering majority of muscles not excitable
- Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders
- Has autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled orthostatic hypotension that may interfere with rehabilitation.
- Requires ventilator support
- Has an autoimmune etiology of spinal cord dysfunction/injury
Show all 13Show fewer
- Has spasms that limit the ability to participate in the study training (as determined by the Investigator)
- Has skin breakdown in area(s) that will come into contact with electrodes
- Has any active implanted medical device
- Is pregnant, planning to become pregnant or currently breastfeeding
- Has concurrent participation in another drug or device trial that may interfere with this study
- Has other traumatic injuries such as peripheral nerve injuries, severe musculoskeletal injuries (e.g., shattered pelvis, long bone fractures), that prevent evaluation of response to or participation in rehabilitation.
- Is deemed ineligible because the investigators believe the study would not be safe or appropriate for the individual
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Reynolds Innovative Spinal Electrical Stimulation (RISES) Program: Transcutaneous Spinal Cord Stimulation
The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of "smart" electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.
Read the detailed description
This trial is investigating the use of transcutaneous spinal cord stimulation, where the electrical stimulation is delivered non-invasively via surface electrodes placed on the skin along the spine. The trial will have two phases: open-loop transcutaneous spinal cord stimulation (SCS) phase (where stimulation parameters are selected and subsequently fixed for each stimulation sessions) and closed-loop transcutaneous SCS phase, (where stimulation parameters are continuously revised in real-time during each session based upon the exact movement state of the person as captured by wearable kinematic and electromyographic sensors). For both open-loop and closed-loop phases, the transcutaneous spinal cord stimulation will be incorporated into Functional Task Practice (FTP) sessions guided closely by a team of trained technicians and occupational and physical therapists.
Upon enrollment, participants will complete a baseline assessment of outcome measures validated for spinal cord injury rehabilitation. They will also undergo mapping with sensors of their movements without stimulation to simply characterize their unique "motor signature". Then they will undergo the same mapping with open-loop transcutaneous SCS applied to determine if and how stimulation at a variety of settings can modify their unique "motor signature". They will then participate in the open-loop phase - 15 open-loop SCS+FTP sessions - after which they will repeat the outcome measures (interim assessment). They will then proceed to the closed-loop phase - 15 closed-loop SCS+FTP sessions - after which they will repeat the outcome measures a final time (endpoint assessment).
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- RISES-T System, Occupational/Physical Therapy
- Keywords
- Spinal Cord Injuries, Spinal Electrical Stimulation, Transcutaneous Spinal Stimulation
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISES-T SystemDevice
Also called Transcutaneous spinal stimulation
Non-invasive closed-loop electrical stimulation of the spinal cord through the skin
Occupational/Physical TherapyOther
Also called Functional Task Practice
Exercise therapy to improve function of upper and/or lower limbs
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions. Receives: Device: RISES-T System; Other: Occupational/Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Standard neurological assessment for determining level and severity of impairment after spinal cord injury. It includes a sensory exam (dermatological light touch and pin prick) and motor exam (manual muscle strength testing).
Measured: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Secondary outcomes (4)
Change from Baseline - Spinal Cord Independence Measures (SCIM)
Validated measure that evaluates self-care (feeding, grooming, bathing, dressing), respiration and sphincter management, and mobility abilities (transfers and indoor/outdoor).
Measured: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from Baseline - Canadian Occupational Performance Measure (COPM)
Participant-centered instrument that measures changes in how participants perceive their own functional performance and challenges in daily living; participants identify goals of most importance to them in areas of functional tasks and occupational performance including self-care, leisure, and productivity.
Measured: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from Baseline - Capabilities of Upper Extremity (CUE-T)
Validated objective measure of upper extremity functional capabilities in persons with SCI; evaluates the ability to perform various actions (reach up, pull up, picking up a pencil with tips of fingers).
Measured: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II)
Validated performance measures to assess walking speed and amount of physical assistance needed/assistive devices required for walking respectively.
Measured: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start10 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Kessler Foundation
- Responsible party
- Principal investigator, Mijail Demian Serruya, Thomas Jefferson University
- Investigators
- Mijail D Serruya, MD, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669508
- Sponsor's protocol ID
- Rises-T 22D.126
- Acronym
- RISES-T
- Status last verified
- Apr 2025
- First submitted
- 16 Nov 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
PubMed 26205686Manson G, Atkinson DA, Shi Z, Sheynin J, Karmonik C, Markley RL, Sayenko DG. Transcutaneous spinal stimulation alters cortical and subcortical activation patterns during mimicked-standing: A proof-of-concept fMRI study. Neuroimage Rep. 2022 Jun;2(2):100090. doi: 10.1016/j.ynirp.2022.100090. Epub 2022 Mar 8.
PubMed 36212800Kumru H, Rodriguez-Canon M, Edgerton VR, Garcia L, Flores A, Soriano I, Opisso E, Gerasimenko Y, Navarro X, Garcia-Alias G, Vidal J. Transcutaneous Electrical Neuromodulation of the Cervical Spinal Cord Depends Both on the Stimulation Intensity and the Degree of Voluntary Activity for Training. A Pilot Study. J Clin Med. 2021 Jul 25;10(15):3278. doi: 10.3390/jcm10153278.
PubMed 34362062Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.
PubMed 33192348Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.
PubMed 35160091Capogrosso M, Wagner FB, Gandar J, Moraud EM, Wenger N, Milekovic T, Shkorbatova P, Pavlova N, Musienko P, Bezard E, Bloch J, Courtine G. Configuration of electrical spinal cord stimulation through real-time processing of gait kinematics. Nat Protoc. 2018 Sep;13(9):2031-2061. doi: 10.1038/s41596-018-0030-9.
PubMed 30190556Wenger N, Moraud EM, Gandar J, Musienko P, Capogrosso M, Baud L, Le Goff CG, Barraud Q, Pavlova N, Dominici N, Minev IR, Asboth L, Hirsch A, Duis S, Kreider J, Mortera A, Haverbeck O, Kraus S, Schmitz F, DiGiovanna J, van den Brand R, Bloch J, Detemple P, Lacour SP, Bezard E, Micera S, Courtine G. Spatiotemporal neuromodulation therapies engaging muscle synergies improve motor control after spinal cord injury. Nat Med. 2016 Feb;22(2):138-45. doi: 10.1038/nm.4025. Epub 2016 Jan 18.
PubMed 26779815Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
PubMed 29877852Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
PubMed 30382197
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reynolds Innovative Spinal Electrical Stimulation (RISES) Program: Transcutaneous Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT05669508
- Acronym / sponsor ID
- RISES-T / Rises-T 22D.126
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Keywords
- Spinal Cord Injuries, Spinal Electrical Stimulation, Transcutaneous Spinal Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Kessler Foundation
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jan 2023 (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 goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of "smart" electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.
Detailed description
This trial is investigating the use of transcutaneous spinal cord stimulation, where the electrical stimulation is delivered non-invasively via surface electrodes placed on the skin along the spine. The trial will have two phases: open-loop transcutaneous spinal cord stimulation (SCS) phase (where stimulation parameters are selected and subsequently fixed for each stimulation sessions) and closed-loop transcutaneous SCS phase, (where stimulation parameters are continuously revised in real-time during each session based upon the exact movement state of the person as captured by wearable kinematic and electromyographic sensors). For both open-loop and closed-loop phases, the transcutaneous spinal cord stimulation will be incorporated into Functional Task Practice (FTP) sessions guided closely by a team of trained technicians and occupational and physical therapists.
Upon enrollment, participants will complete a baseline assessment of outcome measures validated for spinal cord injury rehabilitation. They will also undergo mapping with sensors of their movements without stimulation to simply characterize their unique "motor signature". Then they will undergo the same mapping with open-loop transcutaneous SCS applied to determine if and how stimulation at a variety of settings can modify their unique "motor signature". They will then participate in the open-loop phase - 15 open-loop SCS+FTP sessions - after which they will repeat the outcome measures (interim assessment). They will then proceed to the closed-loop phase - 15 closed-loop SCS+FTP sessions - after which they will repeat the outcome measures a final time (endpoint assessment).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: RISES-T System, Other: Occupational/Physical TherapyParticipants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Has a non-progressive or central cord spinal cord injury from C2-T10 inclusive
- Has American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
- Can participate in physical and occupational therapy rehabilitation programs
- Is at minimum 12 months post- spinal cord injury
- Can provide informed consent
Key exclusion criteria (13 listed)
- Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by the Investigator)
- Has diffuse lower motor neuron injury rendering majority of muscles not excitable
- Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders
- Has autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled orthostatic hypotension that may interfere with rehabilitation.
- Requires ventilator support
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 |
|---|---|---|
| RISES-T SystemAlso: Transcutaneous spinal stimulationNon-invasive closed-loop electrical stimulation of the spinal cord through the skin | Device | Treatment Arm |
| Occupational/Physical TherapyAlso: Functional Task PracticeExercise therapy to improve function of upper and/or lower limbs | Other | Treatment Arm |
Primary outcome
Change from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Standard neurological assessment for determining level and severity of impairment after spinal cord injury. It includes a sensory exam (dermatological light touch and pin prick) and motor exam (manual muscle strength testing).
4 secondary outcomes
Change from Baseline - Spinal Cord Independence Measures (SCIM)
Time frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from Baseline - Canadian Occupational Performance Measure (COPM)
Time frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from Baseline - Capabilities of Upper Extremity (CUE-T)
Time frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
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 11 Apr 2025.
- Background: PubMed 26205686Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
- Background: PubMed 36212800Manson G, Atkinson DA, Shi Z, Sheynin J, Karmonik C, Markley RL, Sayenko DG. Transcutaneous spinal stimulation alters cortical and subcortical activation patterns during mimicked-standing: A proof-of-concept fMRI study. Neuroimage Rep. 2022 Jun;2(2):100090. doi: 10.1016/j.ynirp.2022.100090. Epub 2022 Mar 8.
- Background: PubMed 34362062Kumru H, Rodriguez-Canon M, Edgerton VR, Garcia L, Flores A, Soriano I, Opisso E, Gerasimenko Y, Navarro X, Garcia-Alias G, Vidal J. Transcutaneous Electrical Neuromodulation of the Cervical Spinal Cord Depends Both on the Stimulation Intensity and the Degree of Voluntary Activity for Training. A Pilot Study. J Clin Med. 2021 Jul 25;10(15):3278. doi: 10.3390/jcm10153278.
- Background: PubMed 33192348Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.
- Background: PubMed 35160091Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.
- Background: PubMed 30190556Capogrosso M, Wagner FB, Gandar J, Moraud EM, Wenger N, Milekovic T, Shkorbatova P, Pavlova N, Musienko P, Bezard E, Bloch J, Courtine G. Configuration of electrical spinal cord stimulation through real-time processing of gait kinematics. Nat Protoc. 2018 Sep;13(9):2031-2061. doi: 10.1038/s41596-018-0030-9.
- Background: PubMed 26779815Wenger N, Moraud EM, Gandar J, Musienko P, Capogrosso M, Baud L, Le Goff CG, Barraud Q, Pavlova N, Dominici N, Minev IR, Asboth L, Hirsch A, Duis S, Kreider J, Mortera A, Haverbeck O, Kraus S, Schmitz F, DiGiovanna J, van den Brand R, Bloch J, Detemple P, Lacour SP, Bezard E, Micera S, Courtine G. Spatiotemporal neuromodulation therapies engaging muscle synergies improve motor control after spinal cord injury. Nat Med. 2016 Feb;22(2):138-45. doi: 10.1038/nm.4025. Epub 2016 Jan 18.
- Background: PubMed 29877852Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
- Background: PubMed 30382197Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
- 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. This study is not recruiting at the moment.
Mijail D Serruya, MD, PhD principal investigator
Thomas Jefferson 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 RISES-T System and Occupational/Physical Therapy in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Thomas Jefferson University 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 13 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 11 Apr 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 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. 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 from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (time frame: Repeated measurements once every 6 weeks throughout the study, an average of 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 NCT05669508, which also lists 9 linked publications.
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 11 Apr 2025.