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Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

Primary Purpose

Paralysis, 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 treatment trial for Paralysis focused on measuring spinal cord injury, quadriplegia, tetraplegia, stimulation

Eligibility Criteria

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

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

Sites / Locations

  • University of California Los Angeles
  • Strides SCI Functional Fitness

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Control Grp#1: Training w/ and w/o Stim

Grp#2: Training+Single Site Stimulation

Grp #3: Training + Two Site Stimualtion

Arm Description

Control- Group #1: 4 weeks training without any transcutaneous electrical stimulation followed by 2 weeks of training plus transcutaneous electrical spinal cord stimulation applied to one or two locations of the cervical (neck) region of the spinal cord.

Group #2: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to one location along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation

Group #3: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to two locations along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation

Outcomes

Primary Outcome Measures

Improvement in sensorimotor function in arms and hands
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)

Secondary Outcome Measures

Full Information

First Posted
July 16, 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
NCT01906424
Brief Title
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Official Title
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (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
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralysis, Spinal Cord Injury
Keywords
spinal cord injury, quadriplegia, tetraplegia, stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Grp#1: Training w/ and w/o Stim
Arm Type
Other
Arm Description
Control- Group #1: 4 weeks training without any transcutaneous electrical stimulation followed by 2 weeks of training plus transcutaneous electrical spinal cord stimulation applied to one or two locations of the cervical (neck) region of the spinal cord.
Arm Title
Grp#2: Training+Single Site Stimulation
Arm Type
Active Comparator
Arm Description
Group #2: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to one location along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation
Arm Title
Grp #3: Training + Two Site Stimualtion
Arm Type
Active Comparator
Arm Description
Group #3: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to two locations along the cervical (neck) region of the spinal cord; followed by 2 weeks of training 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 delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Primary Outcome Measure Information:
Title
Improvement in sensorimotor function in arms and hands
Description
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)
Time Frame
12 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: 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
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 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
Facility Name
Strides SCI Functional Fitness
City
San Juan Capistrano
State/Province
California
ZIP/Postal Code
92675
Country
United States

12. IPD Sharing Statement

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