Health TrialsbyHealthPanel

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

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Open-loop Stimulation

    Device

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

  • 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.

  • Functional Task Practice

    Other intervention

    Exercise therapy consists of repeated functional hand and arm movements

Treatment groups

9 Participants
are divided into 2 treatment groups
Group A: Open-loop StimulationExperimental treatment 2 interventions
Group B: Close-loop StimulationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
"Repeated measurements once every two weeks throughout the study, an average of 10 months".
2

Change from baseline- Capabilities of Upper Extremity Test

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

Time frame
"Repeated measurements once every two weeks throughout the study, an average of 10 months".
3

Change from baseline- Grip and Pinch Force

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

Time frame
"Repeated measurements once every two weeks throughout the study, an average of 10 months".
4

Change from baseline- Modified Ashworth Scale

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

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

Secondary outcomes

1

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

Standard manual muscle strength examination (Range 0-100 points, higher score mean better outcome)

Time frame
"Repeated measurements once every eight weeks throughout the study, an average of 10 months".
2

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

Standard examination of dermatomal sensation (range 0-224 points, higher score mean better outcome)

Time frame
"Repeated measurements once every eight weeks throughout the study, an average of 10 months".
3

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

Clinician assessment to document remaining autonomic functions after spinal cord injury

Time frame
"Repeated measurements once every eight weeks throughout the study, an average of 10 months".
4

Change from baseline- H-Reflex

Electrophysiologic measurement of H-reflex (lower Hmax/Mmax ratio mean better outcome)

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

Other outcomes

1

Change from baseline- World Health Organization Quality of Life Questionnaire

Self-reported questionnaire on quality of life (range 0-100 points, higher score mean better outcome)

Time frame
"Repeated measurements once every eight weeks throughout the study, an average of 10 months".
2

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

Patient-reported questionnaire (range 0-100 points, higher score mean better outcome)

Time frame
"Baseline"/"At the end of each treatment arm"/"Through study completion"
3

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

Patient-reported questionnaire (range 0-47 points, lower score mean better outcome)

Time frame
"Repeated measurements once every eight weeks throughout the study, an average of 10 months".
4

Change from baseline- Patient Reported Impact of Spasticity Measure

Patient-reported questionnaire (range 0-164 points, lower score mean better outcome)

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
Apply now