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

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Treatments: Behavioral: Remote Exercise; Behavioral: Remote CMR

Study type: Interventional

Funder types: Other

Identifiers

NCT05870189

CMR

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

19 participants in 2 patient groups, including a placebo group

Remote CMR

Experimental group

Description:

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

Treatment:

Behavioral: Remote CMR

Remote exercises

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Remote Exercise