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Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01906424
Recruitment Status : Completed
First Posted : July 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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Paralysis 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Study Start Date : April 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Device: Transcutaneous Electrical Spinal Cord Stimulation
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Name: 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
 Device: Transcutaneous Electrical Spinal Cord Stimulation
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Name: 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
 Device: Transcutaneous Electrical Spinal Cord Stimulation
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Name: Prototype device


Outcome Measures
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Primary Outcome Measures :
  1. 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)



Eligibility Criteria
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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: 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
Contacts and Locations
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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): NCT01906424


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Strides SCI Functional Fitness
San Juan Capistrano, California, United States, 92675
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 Terrafranca, DPM NeuroEnabling Technologies, Inc.
More Information
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Responsible Party: NeuroEnabling Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01906424    
Other Study ID Numbers: NETI201307
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: April 2016
Keywords provided by NeuroEnabling Technologies, Inc.:
spinal cord injury
quadriplegia
tetraplegia
stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Paralysis
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations