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

Phase 2

Recruiting

• Conditions: Spinal Cord Injuries; Spinal Cord Diseases
• Interventions: Behavioral: Remote Exercise; Behavioral: Remote CMR

• Registration Number: NCT05870189
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-23
• Study Start: 2023-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote exercises	Remote Exercise	adults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention.
Remote CMR	Remote CMR	adults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention.

Primary Outcome Measures

Name	Time	Method
the Neuromuscular Recovery Scale (NRS)	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	12 weeks	(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam	12 weeks	a clinical test originally designed to describe the extent and severity of a patient's SCI/D

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States