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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.

Tracking Information
First Submitted Date  ICMJE July 16, 2013
First Posted Date  ICMJE July 24, 2013
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2015)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2013)
Improvement in sensorimotor function in arms and hands [ Time Frame: 18 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) ARAT (Action Research Arm Test)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Official Title  ICMJE Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Paralysis
  • Spinal Cord Injury
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Transcutaneous Electrical Spinal Cord Stimulation
  • 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
    Intervention: Device: Transcutaneous Electrical Spinal Cord Stimulation
  • 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
    Intervention: Device: Transcutaneous Electrical Spinal Cord Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2017)
7
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2013)
24
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01906424
Other Study ID Numbers  ICMJE NETI201307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NeuroEnabling Technologies, Inc.
Study Sponsor  ICMJE NeuroEnabling Technologies, Inc.
Collaborators  ICMJE
  • University of California, Los Angeles
  • California Institute of Technology
Investigators  ICMJE
Study Chair: Victor R Edgerton, PhD University of California, Los Angeles
Principal Investigator: Nicholas Terrafranca, DPM NeuroEnabling Technologies, Inc.
PRS Account NeuroEnabling Technologies, Inc.
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP