NCT05870189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

April 28, 2023

Last Update Submit

July 6, 2025

Conditions

Spinal Cord InjuriesSpinal Cord Diseases

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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.

    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.

    12 weeks

  • The SCI-FI/AT

    (32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.

    baseline

  • The SCI-FI/AT

    (32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.

    12 weeks

Study Arms (2)

Remote CMR

EXPERIMENTAL

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

Behavioral: Remote CMR

Remote exercises

PLACEBO COMPARATOR

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

Behavioral: Remote Exercise

Interventions

Remote CMRBEHAVIORAL

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

Remote CMR
Remote ExerciseBEHAVIORAL

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

Remote exercises

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesSpinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 23, 2023

Study Start

June 1, 2023

Primary Completion

March 11, 2025

Study Completion

June 30, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

US(1)