Status:
COMPLETED
Pilot Trial of a System for Motor Function Recovery
Lead Sponsor:
Niche Biomedical, Inc. dba ANEUVO
Conditions:
Spinal Cord Diseases
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.
Eligibility Criteria
Inclusion
- Traumatic chronic spinal cord injury
Exclusion
- 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
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04683471
Start Date
November 30 2020
End Date
March 22 2022
Last Update
April 13 2022
Active Locations (3)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
2
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
3
Houston Methodist Research Institute
Houston, Texas, United States, 77030