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Completed

NCT Number: NCT01949285

Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

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, 90095, United States

About this study

This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

The investigators hypothesize that this type of stimulation can be used to locate and determine if any spinal (nerve) pathways or connections were spared following a spinal cord injury. We also hypothesize the same stimulation can help revive or recover function to muscles connected to these spared spinal (nerve) pathways in individuals who are clinically paralyzed. Our research has demonstrated that modifying the activation state of the spinal cord after an injury, 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 one day to gain FDA approval.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

SCI ASIA A, B, C

  • Spinal cord injury 1 or more years prior
  • Non progressive cervical or thoracic SCI
  • Half of key muscles below neurological level having a motor score of less than 2/5
  • Ability to commit to home exercises and 16 week participation
  • Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in lower 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 lower 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 16 week study period
  • No current anti-spasticity regimen
  • Must not have received botox injections in the prior six months
  • Be unable to use lower 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 non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.

Other names: Prototype Device

Primary outcomes

  1. Improvement in sensorimotor function in the lower extremities

    Time frame: 10-12 weeks

    Subjects will be tested by several measures of sensory and motor function, as well as self assessments of spasticity, quality of life, and independence. These tests include:

    American Spinal Injury Association (ASIA) scoring system, Spinal Cord Independence Measure (SCIM), Ashworth Spasticity Scale, Penn Spasm Frequency, Visual Analog Scale (VAS) for Spasticity, Electromyographic (EMG) recordings, Joint angle (goniometer) measures, kinematic analysis.

Secondary outcomes

  1. Ability to stand independently

    Time frame: 2-4 weeks

    Subjects will be evaluated on their core body function and ability to stand

Sponsors and collaborators

Lead sponsor

NeuroEnabling Technologies, Inc.

Industry

Collaborators

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

Registry information

Official study title

A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 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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