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NCT05870189 | Recruiting | Spinal Cord Injuries

Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Sponsor:

University of Minnesota

Brief 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 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.

Condition or disease

Spinal Cord Injuries

Spinal Cord Diseases

Intervention/treatment

Remote CMR

Remote Exercise

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 22 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025
Arm Intervention/treatment

Experimental: Remote CMR

adults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention.

Behavioral: Remote CMR

Placebo Comparator: Remote exercises

adults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention.

Behavioral: Remote Exercise
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury

Location Details

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Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455