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Completed

NCT Number: NCT01906424

Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles, Los Angeles, California, United States

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About this study

This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury. The investigators hypothesize that this stimulation can revive spared function in the spinal cord of individuals who are clinically paralyzed, but who have some remaining connections between the brain and spinal cord. Our research has demonstrated that modifying the activation state of the spinal cord or awakening the spinal cord can benefit people with paralysis years after a spinal cord injury. This method and device have not yet been approved by the FDA for the treatment of paralysis and are under investigation. This study if successful will help provide further evidence that could be use to gain FDA approval.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

ASIA C

  • Spinal cord injury 1 or more years prior
  • Non progressive SCI at C7 or higher
  • Half of key muscles below neurological level having a motor score of less than 2/5
  • Ability to commit to home exercises and 12 week participation
  • Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities
  • Not dependent on ventilation support
  • No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with upper extremity rehabilitation or testing activities
  • No clinically significant depression or ongoing drug abuse
  • Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 12 week study period
  • No current anti-spasticity regimen
  • Must not have received botox injections in the prior six months
  • Be unable to use upper extremity for functional tasks

Exclusion criteria

  • Pregnancy
  • No functional segmental reflexes below the lesion

Treatment and study plan

Transcutaneous Electrical Spinal Cord Stimulation

Device

A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.

Other names: Prototype device

Primary outcomes

  1. Improvement in sensorimotor function in arms and hands

    Time frame: 12 weeks

    Subjects will be tested by several measures of sensory and motor function, as well as self-assessments regarding quality of life and independence, at the beginning of the study and at each testing session. These tests include:

    American Spinal Injury Association (ASIA) scoring system. Box and block CUE (Capabilities of Upper Extremity) GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension) SCIM (Spinal Cord Independence Measure)

    Ashworth Spasticity scale:

    Penn Spasm Frequency VAS (Visual Analog Scale) for Spasticity)

Sponsors and collaborators

Lead sponsor

NeuroEnabling Technologies, Inc.

Industry

Collaborators

  • California Institute of Technology
  • University of California, Los Angeles

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2013
Registry last updated
Jan 24, 2017

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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