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Pilot Trial of a System for Motor Function Recovery

Primary Purpose

Spinal Cord Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulator
Sham
Sponsored by
Niche Biomedical, Inc. dba ANEUVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Diseases

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLab
  • Kennedy Krieger Institute
  • Houston Methodist Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Neuromodulation

Sham

Arm Description

Neuromodulation

Sham

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2020
Last Updated
April 11, 2022
Sponsor
Niche Biomedical, Inc. dba ANEUVO
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1. Study Identification

Unique Protocol Identification Number
NCT04683471
Brief Title
Pilot Trial of a System for Motor Function Recovery
Official Title
Pilot Feasibility Clinical Validation Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niche Biomedical, Inc. dba ANEUVO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromodulation
Arm Type
Experimental
Arm Description
Neuromodulation
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham
Intervention Type
Device
Intervention Name(s)
Stimulator
Intervention Description
Neuromodulation
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Sham
Primary Outcome Measure Information:
Title
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Description
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
Time Frame
Biweekly through study completion up to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Trial of a System for Motor Function Recovery

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