Pilot Trial of a System for Motor Function Recovery

Spinal Cord Diseases Clinical Trial

Official title:

Pilot Feasibility Clinical Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683471
• Other study ID #: EXA-2001
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: March 22, 2022

Study information

• Verified date: April 2022
• Source: Niche Biomedical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 22, 2022
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Traumatic chronic spinal cord injury

Exclusion Criteria:

• Active implanted medical device

• Internal metallic objects of unknown or foreign origin

• Implanted anti-spasticity pumps, Botox injections in prior 3 months or other current anti-spasticity regimen

• BMI > 40.0

• Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds

• Pregnancy or planned pregnancy

• Unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction

• Cardiopulmonary disease or ventilator dependency

• Uncontrolled epilepsy or seizures

• Clinically significant depression, psychiatric disorders or ongoing substance abuse

Related Conditions & MeSH terms

• Spinal Cord Diseases

Intervention

Device:
• Stimulator
Neuromodulation
• Sham
Sham

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	Houston Methodist Research Institute	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Niche Biomedical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) for the upper limbs; Scoring: Strength scored 0 - 50 for each arm; Sensibility scored 0 - 24 for each arm; Prehension scored 0 - 42 for each arm; Higher scores are a better outcome	Biweekly through study completion up to 18 weeks