Spinal Cord InjuriesPhase 2NCT05870189
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
A Phase 2 study testing Remote CMR and Remote Exercise in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Minnesota at 1 site in United States.
Trial summary
So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases
- What is being tested?
- Remote CMR and Remote Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old, with an incomplete or complete SCI/D of ≥ 3months, medically stable.
- be recruited from Hospitals within the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS), HealthPartners Neuroscience Center, Minneapolis VA Healthcare System, Duluth, and in the community.
Who cannot join
- adults with MRI contra-indications (stabilizing hardware is typically MRI safe);
- adults with uncontrolled seizure disorder;
- adults with cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent them from following directions or from learning;
- adults with with ventilator dependency;
- adults with other major medical complications
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- Remote CMR, Remote Exercise
- 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.
Remote CMRBehavioural
12 weeks of remote CMR is done 3x/week, 45 min/session.
Remote ExerciseBehavioural
12 weeks of remote exercise is done 3x/week, 45 min/session.
| Study group | Role | What they receive |
|---|---|---|
| Remote CMR | Experimental | adults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention. Receives: Behavioral: Remote CMR |
| Remote exercises | Placebo comparator | adults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention. Receives: Behavioral: Remote Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
Measured: baseline
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
Measured: 12 weeks
the Neuromuscular Recovery Scale (NRS)
includes 11 items focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. The NRS provides a functional recovery measure that focuses on non-compensatory recovery.
Measured: baseline
the Neuromuscular Recovery Scale (NRS)
includes 11 items focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. The NRS provides a functional recovery measure that focuses on non-compensatory recovery.
Measured: 12 weeks
The SCI-FI/AT
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
Measured: baseline
The SCI-FI/AT
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jun 2023
- Primary completion11 Mar 2025
- Study completion30 Jun 2025
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 InjuriesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870189
- Sponsor's protocol ID
- CMR
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van de Winckel A, Herrmann AA, Carpentier ST, Bottale S, Lopez RL, Rapacz AD, Larson SJ, Deng W, Zhang L, Hendrickson TJ, Mueller BA, Nourian R, Morse LR, Lim KO. Sensorimotor recovery and neuropathic pain reduction after remotely delivered cognitive multisensory rehabilitation or remotely delivered exercise in adults with spinal cord injury: a pilot clinical trial. medRxiv [Preprint]. 2026 Jun 9:2026.06.02.26354574. doi: 10.64898/2026.06.02.26354574.
PubMed 42326828
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05870189
- Acronym / sponsor ID
- CMR
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 May 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.
So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote CMR | Experimental | Behavioral: Remote CMRadults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention. |
| Remote exercises | Placebo comparator | Behavioral: Remote Exerciseadults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-75 years old, with an incomplete or complete SCI/D of ≥ 3months, medically stable.
- be recruited from Hospitals within the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS), HealthPartners Neuroscience Center, Minneapolis VA Healthcare System, Duluth, and in the community.
Key exclusion criteria (6 listed)
- adults with MRI contra-indications (stabilizing hardware is typically MRI safe);
- adults with uncontrolled seizure disorder;
- adults with cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent them from following directions or from learning;
- adults with with ventilator dependency;
- adults with other major medical complications
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 |
|---|---|---|
| Remote CMR12 weeks of remote CMR is done 3x/week, 45 min/session. | Behavioural | Remote CMR |
| Remote Exercise12 weeks of remote exercise is done 3x/week, 45 min/session. | Behavioural | Remote exercises |
Primary outcome
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
Time frame: baseline
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
Time frame: 12 weeks
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
the Neuromuscular Recovery Scale (NRS)
Time frame: baseline
includes 11 items focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. The NRS provides a functional recovery measure that focuses on non-compensatory recovery.
the Neuromuscular Recovery Scale (NRS)
Time frame: 12 weeks
includes 11 items focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. The NRS provides a functional recovery measure that focuses on non-compensatory recovery.
The SCI-FI/AT
Time frame: baseline
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
The SCI-FI/AT
Time frame: 12 weeks
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 42326828Van de Winckel A, Herrmann AA, Carpentier ST, Bottale S, Lopez RL, Rapacz AD, Larson SJ, Deng W, Zhang L, Hendrickson TJ, Mueller BA, Nourian R, Morse LR, Lim KO. Sensorimotor recovery and neuropathic pain reduction after remotely delivered cognitive multisensory rehabilitation or remotely delivered exercise in adults with spinal cord injury: a pilot clinical trial. medRxiv [Preprint]. 2026 Jun 9:2026.06.02.26354574. doi: 10.64898/2026.06.02.26354574.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remote CMR and Remote Exercise in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Minnesota 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jul 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT05870189, 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 8 Jul 2025.