Pilot Trial of a System for Motor Function Recovery

NCT ID: NCT04683471

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-03-22

Brief Summary

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

Detailed Description

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Conditions

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Spinal Cord Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Neuromodulation

Neuromodulation

Group Type EXPERIMENTAL

Stimulator

Intervention Type DEVICE

Neuromodulation

Sham

Sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Sham

Interventions

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Stimulator

Neuromodulation

Intervention Type DEVICE

Sham

Sham

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Niche Biomedical, Inc. dba ANEUVO

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status

Kennedy Krieger Institute

Baltimore, Maryland, United States

Site Status

Houston Methodist Research Institute

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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EXA-2001

Identifier Type: -

Identifier Source: org_study_id

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