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OpenTrials
Completed

NCT Number: NCT05870189

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote CMR

Behavioral

12 weeks of remote CMR is done 3x/week, 45 min/session.

Remote Exercise

Behavioral

12 weeks of remote exercise is done 3x/week, 45 min/session.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 23, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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