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Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury (ADDRESS)

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ClinicalTrials.gov Identifier: NCT03184792
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Chet Moritz, University of Washington

Brief Summary:

Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network.

This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury.

The interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Cervical Upper Extremity Dysfunction Device: Transcutaneous spinal stimulation Other: Physical therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
Actual Study Start Date : December 27, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Transcutaneous spinal stimulation & Physical therapy
Transcutaneous cervical electrical stimulation combined with physical therapy that targets rehabilitation of upper extremity functions
Device: Transcutaneous spinal stimulation
Non-invasive electrical stimulation of cervical spinal cord over the skin

Other: Physical therapy
Physical therapy to improve arm and hand functions
Other Name: Exercise therapy

Active Comparator: Physical therapy only
Physical therapy that targets rehabilitation of upper extremity functions
Other: Physical therapy
Physical therapy to improve arm and hand functions
Other Name: Exercise therapy




Primary Outcome Measures :
  1. Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP test) [ Time Frame: 6 months ]
    GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function, including strength (manual muscle strength testing), sensibility (Semmes Weinstein monofilament sensation test) and prehension (ability and performance to generate various grasp and pinch movements using water bottle, jar, key, pegs, coins and nuts).


Secondary Outcome Measures :
  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination [ Time Frame: 6 months ]
    Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination.

  2. Grip and pinch strength [ Time Frame: 6 months ]
    Hand strength measurement by grip and pinch dynamometry

  3. Numeric Pain Rating Scale [ Time Frame: 6 months ]
    Patient reported pain rating

  4. Penn Spasm score [ Time Frame: 6 months ]
    Patient reported spasm rating

  5. Spinal Cord Independence Measure [ Time Frame: 6 months ]
    Clinician-administered disability questionnaire for patients with spinal cord lesions

  6. WHO-Quality of life - BREF [ Time Frame: 6 months ]
    Patient reported quality of life scale

  7. Somatosensory Evoked Potentials (SSEP) [ Time Frame: 6 months ]
    Measurement of latency and amplitude of electrical potentials that are recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist.

  8. Motor Evoked Potentials (MEP) [ Time Frame: 6 months ]
    Measurement of latency and amplitude of electrical potentials that are recorded by surface electrodes over the skin of limb muscles following magnetic stimulation of brain over the scalp.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cervical (C7 or higher) spinal cord injury at least 1 year duration
  • Between 21 and 70 years of age
  • Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
  • Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
  • Capable of performing simple cued motor tasks
  • Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing activities
  • Adequate social support to be able to participate in weekly training and assessment sessions for the duration of 6 months within the study period.
  • Ability to read and speak English

Exclusion Criteria:

  • Autoimmune etiology of spinal cord dysfunction/injury
  • History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
  • Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
  • Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • Significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
  • Active cancer
  • Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
  • Unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with upper extremity rehabilitation or testing activities
  • Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
  • Pregnancy
  • Currently on anti-spasticity medication regimen
  • Botulinum toxin injections in the prior 6 months
  • Dependent on ventilation support
  • Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc).
  • Has depression or anxiety based on Patient Health Questionnaire and General Anxiety Disorder-7 item Questionnaire
  • Alcohol and/or drug abuse.
  • Cognitive impairment based on Short Portable Mental Status Questionnaire
  • Unable to read and/or comprehend the consent form.
  • Unable to understand the instructions given as part of the study.

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): NCT03184792


Contacts
Contact: Fatma Inanici, MD 206 787-2692 finanici@uw.edu
Contact: Chet Moritz, PhD 206 221-2842 ctmoritz@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 981095
Contact: Fatma Inanici       finanici@uw.edu   
Contact: Chet Moritz       ctmoritz@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Chet T Moritz, PhD University of Washington

Responsible Party: Chet Moritz, Associate Professor, Rehabilitative Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03184792     History of Changes
Other Study ID Numbers: STUDY00002985
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Chet Moritz, University of Washington:
Spinal electrical stimulation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Musculoskeletal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System