Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury

NCT05267951 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00013469
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2

  Measurement of upper limb strength, sensation, qualitative prehension, and quantitative prehension (range 0-188, higher score mean better outcome)

  "Repeated measurements once every two weeks throughout the study, an average of 10 months".

• Change from baseline- Capabilities of Upper Extremity Test

  Measures unilateral and bilateral hand and arm function (range 0-128, higher score mean better outcome)

  "Repeated measurements once every two weeks throughout the study, an average of 10 months".

• Change from baseline- Grip and Pinch Force

  Grip and pinch force measurement using a dynamometer (higher score mean better outcome)

  "Repeated measurements once every two weeks throughout the study, an average of 10 months".

• Change from baseline- Modified Ashworth Scale

  Clinician administered assessment of spasticity (range 0-4, lower score mean better outcome)

  "Repeated measurements once every two weeks throughout the study, an average of 10 months".

Secondary Outcomes (7)

• Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score

  "Repeated measurements once every eight weeks throughout the study, an average of 10 months".

• Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Sensory Score

  "Repeated measurements once every eight weeks throughout the study, an average of 10 months".

• Change from baseline- International Standards of Autonomic Functions after Spinal Cord Injury

  "Repeated measurements once every eight weeks throughout the study, an average of 10 months".

• Change from baseline- H-Reflex

  "Repeated measurements once every eight weeks throughout the study, an average of 10 months".

• Change from baseline- Somatosensory Evoked Potentials

  "Repeated measurements once every eight weeks throughout the study, an average of 10 months".

Other Outcomes (4)

• Change from baseline- World Health Organization Quality of Life Questionnaire

  "Repeated measurements once every eight weeks throughout the study, an average of 10 months".

• Change from baseline- Spinal Cord Injury - Functional Index Short-Form

  "Baseline"/"At the end of each treatment arm"/"Through study completion"

• Change from baseline- International Spinal Cord Injury Bowel Function Basic Data Set.v.2.1

  "Repeated measurements once every eight weeks throughout the study, an average of 10 months".

Study Arms (2)

Open-loop Stimulation

EXPERIMENTAL

Continuous stimulation

Device: Open-loop Stimulation; Other: Functional Task Practice

Close-loop Stimulation

EXPERIMENTAL

Intended movement-based stimulation.

Device: Close-loop Stimulation; Other: Functional Task Practice

Interventions

Open-loop Stimulation DEVICE

Spinal cord stimulation will be applied continuously over the skin throughout the intervention session.

Open-loop Stimulation

Close-loop Stimulation DEVICE

Spinal cord stimulation will start and stop based on the signals that come from the sensors placed on upper limb muscle surfaces.

Close-loop Stimulation

Functional Task Practice OTHER

Exercise therapy consists of repeated functional hand and arm movements

Also known as: Intensive exercise therapy

Close-loop Stimulation; Open-loop Stimulation

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury
• has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)
• stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
• capable of performing simple cued motor tasks
• has ability to attend intervention/functional task training and assessment sessions 3 times/week
• has adequate social support to participate in all intervention and baseline/follow-up assessment sessions throughout 40 weeks.
• has ability to read and speak English

You may not qualify if:

• dependent on ventilation support
• has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
• has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips/coils, and stents, vagus nerve stimulators)
• has a history or current signs/symptoms of syringomyelia (progressive pain, muscle weakness, and/or sensory loss; deterioration of bowel/bladder function)
• has autoimmune etiology of spinal cord dysfunction/injury
• has received botulinum toxin injections in upper extremity muscles in the prior 6 months
• has tendon transfer or nerve transfer surgery in the upper extremity,
• taking tizanidine, dantrolene or diazepam
• has history of seizures or increased risk for seizures
• has history of chronic headaches or migraines
• has history of neurologic diseases, such as stroke, multiple sclerosis, traumatic brain injury, etc.
• has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
• has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
• has 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
• has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (3)

• Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.

  PMID: 29877852 BACKGROUND

• Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous Spinal Cord Stimulation Restores Hand and Arm Function After Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2021;29:310-319. doi: 10.1109/TNSRE.2021.3049133. Epub 2021 Mar 2.

  PMID: 33400652 BACKGROUND

• McPherson JG, Miller RR, Perlmutter SI. Targeted, activity-dependent spinal stimulation produces long-lasting motor recovery in chronic cervical spinal cord injury. Proc Natl Acad Sci U S A. 2015 Sep 29;112(39):12193-8. doi: 10.1073/pnas.1505383112. Epub 2015 Sep 14.

  PMID: 26371306 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Chet Moritz, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Inanici, MD., Ph.D.

CONTACT

206 787 2692; finanici@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Functional measurements and all other assessments will be done by an examiner who does not know the order of the intervention arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: Division of Physical Therapy

Model Details: Participants who participate in Aim 1 Section of the study will receive open-loop and closed-loop stimulation intervention arms in a randomized order. The order of the two interventions in the Aim 2 Section of the study will be the same for all participants enrolled in the Aim 2 Section of the study.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: March 7, 2022
• Study Start: October 12, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)