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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04683471
Other study ID # EXA-2001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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