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

Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Upper Extremity Dysfunction; Spinal Cord Injury Cervical
• Intervention / Treatment: Device: Transcutaneous spinal stimulation; Other: Physical therapy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chet Moritz, PhD; Phone Number: 206 221-2842; Email: ctmoritz@uw.edu
• Study Contact Backup: Name: Fatma Inanici, MD, PhD; Phone Number: 206 787-2692; Email: finanici@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 981095
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cervical (C7 or higher) spinal cord injury at least 1-year duration
• Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D)
• 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
• Tendon or nerve transfer surgery in the upper limbs
• 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
• Diagnosed with syringomyelia
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Exercise therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP test)	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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination	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.	6 months
Grip and pinch strength	Hand strength measurement by grip and pinch dynamometry	6 months
Numeric Pain Rating Scale	Patient reported pain rating	6 months
Penn Spasm score	Patient reported spasm rating	6 months
Spinal Cord Independence Measure	Clinician-administered disability questionnaire for patients with spinal cord lesions	6 months
WHO-Quality of life - BREF	Patient reported quality of life scale	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Chet T Moritz, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2016
• Primary Completion (Estimated): December 27, 2023
• Study Completion (Estimated): December 27, 2023

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Spinal electrical stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: STUDY00002985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No