Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

January 20, 2017 updated by: NeuroEnabling Technologies, Inc.
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • San Juan Capistrano, California, United States, 92675
        • Strides SCI Functional Fitness

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control Grp#1: Training w/ and w/o Stim
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.
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Names:
  • Prototype device
ACTIVE_COMPARATOR: Grp#2: Training+Single Site Stimulation
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
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Names:
  • Prototype device
ACTIVE_COMPARATOR: Grp #3: Training + Two Site Stimualtion
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
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Names:
  • Prototype device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Victor R Edgerton, PhD, University of California, Los Angeles
  • Principal Investigator: Nicholas Terrafranca, DPM, NeuroEnabling Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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