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OpenTrials
Completed

NCT Number: NCT04683471

Pilot Trial of a System for Motor Function Recovery

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

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Key information

Conditions

Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimulator

Device

Neuromodulation

SHAM

Device

Sham

Primary outcomes

  1. Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

    Time frame: Biweekly through study completion up to 18 weeks

    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

Sponsors and collaborators

Lead sponsor

Niche Biomedical, Inc. dba ANEUVO

Industry

Registry information

Official study title

Pilot Feasibility Clinical Validation Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 24, 2020
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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