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Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

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ClinicalTrials.gov Identifier: NCT01949285
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
University of California, Los Angeles
California Institute of Technology
Information provided by (Responsible Party):
NeuroEnabling Technologies, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Transcutaneous Electrical Spinal Cord Stimulation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI
Study Start Date : June 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Grp#1: sham stimulation

Group #1: Baseline clinical assessment; followed by two weeks training with no stimulation; then four weeks training + sham Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment; then four weeks training + effective non-sham Transcutaneous Spinal Cord Stimulation; repeat clinical assessment.

Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation

Device: Transcutaneous Electrical Spinal Cord Stimulation
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 Name: Prototype Device

Active Comparator: Grp#2: Control

Group #2: Baseline clinical assessment; followed by two weeks training with no Transcutaneous Electrical Spinal Cord Stimulation; then four weeks training + effective Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment.

Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation

Device: Transcutaneous Electrical Spinal Cord Stimulation
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 Name: Prototype Device




Primary Outcome Measures :
  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 Outcome Measures :
  1. Ability to stand independently [ Time Frame: 2-4 weeks ]
    Subjects will be evaluated on their core body function and ability to stand



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949285


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
NeuroEnabling Technologies, Inc.
University of California, Los Angeles
California Institute of Technology
Investigators
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Study Chair: Victor R Edgerton, PhD University of California, Los Angeles
Principal Investigator: Nicholas A Terrafranca, DPM NeuroEnabling Technologies, Inc.

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Responsible Party: NeuroEnabling Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01949285     History of Changes
Other Study ID Numbers: NETI201309
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: April 2016

Keywords provided by NeuroEnabling Technologies, Inc.:
Spinal cord injury
Paralysis
Rehabilitation
Assessment
Theranostics

Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries