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Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Spinal Cord Stimulation
Sponsored by
NeuroEnabling Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injury focused on measuring Spinal cord injury, Paralysis, Rehabilitation, Assessment, Theranostics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Grp#1: sham stimulation

Grp#2: Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in sensorimotor function in the lower extremities
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

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

Full Information

First Posted
September 19, 2013
Last Updated
January 20, 2017
Sponsor
NeuroEnabling Technologies, Inc.
Collaborators
University of California, Los Angeles, California Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01949285
Brief Title
Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs
Official Title
A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroEnabling Technologies, Inc.
Collaborators
University of California, Los Angeles, California Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal cord injury, Paralysis, Rehabilitation, Assessment, Theranostics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grp#1: sham stimulation
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Grp#2: Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Spinal Cord Stimulation
Other Intervention Name(s)
Prototype Device
Intervention Description
A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.
Primary Outcome Measure Information:
Title
Improvement in sensorimotor function in the lower extremities
Description
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.
Time Frame
10-12 weeks
Secondary Outcome Measure Information:
Title
Ability to stand independently
Description
Subjects will be evaluated on their core body function and ability to stand
Time Frame
2-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor R Edgerton, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nicholas A Terrafranca, DPM
Organizational Affiliation
NeuroEnabling Technologies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

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