Clinical trial NCT05591196: Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Official title: Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Chronic Stroke
Keywords: Chronic ischemic stroke
Transcutaneous spinal cord stimulation
Activity based rehabilitation
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, randomized, two-arm cross-over study: All participants will receive one of the two treatment arms one after the other. The order of the treatments will be randomized.
Primary purpose: TREATMENT

Brief summary: The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke.

Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery.

The aims of the study are:

1. to determine the improvements in hand and arm function that result from the combined application of non-invasive spinal stimulation and activity-based rehabilitation. Surface electrodes placed over the skin of the neck will be used for non-invasive electrical stimulation of the spinal cord. Functional task practice will be used for activity-dependent rehabilitation,
2. to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.


Eligibility criteria: Inclusion Criteria:

* Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis
* At least six months post-stroke
* Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit
* Medically and neurologically stable, as determined by medical history and documented physical examination
* For women of childbearing potential, a negative over-the-counter pregnancy test at study entry and willingness to practice adequate contraception during the study
* Ability to attend sessions three times per week
* Adequate social support to participate in all intervention and baseline, follow-up assessment sessions throughout eight months.
* Ability to read, comprehend and speak English

Exclusion Criteria:

* Hemorrhagic stroke
* History of multiple strokes
* Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
* Aphasia or any other deficit in communication that interferes with reasonable study participation
* Moderate to severe cognitive impairment
* Presence of neglect (inability to perceive or awareness of, or loss of attention to the weaker half of the body)
* Severe spasticity in the upper limb
* Taking baclofen more than 30 mg/day
* Change in baclofen dose within four weeks before enrollment
* Receiving benzodiazepines, dantrolene, tizanidine, anticoagulant, or antiepileptic medication
* Botulinum toxin injection to the upper limb muscles within six months before enrollment
* Severe joint contractures in the affected hand and arm
* History of spontaneous seizure that had occurred one month or longer after the stroke

Primary outcomes:
measure: Change from baseline - Fugl-Meyer assessment of the upper limb
timeFrame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
measure: Change from baseline - Pinch and grip force
timeFrame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
measure: Change from baseline - Modified Ashworth Scale
timeFrame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
measure: Change from baseline - Wolf Motor Function Test
timeFrame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
Secondary outcomes:
measure: Change from baseline - Action Research Arm Test
timeFrame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
measure: Change from baseline - Box and Blocks Test
timeFrame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
measure: Change from baseline - Revised Nottingham Sensory Assessment
timeFrame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."
measure: Change from baseline - Stroke Impact Scale
timeFrame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."
measure: Change from baseline - Short Form-36
timeFrame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."
measure: Change from baseline - Patients Global Impression of Change
timeFrame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."
measure: Change from baseline - H-reflex test
timeFrame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."
measure: Change from baseline - Somatosensory evoked potentials test
timeFrame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."
measure: Change from baseline - Spinally evoked motor potentials test
timeFrame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Chet Moritz, PhD
role: PRINCIPAL_INVESTIGATOR
References: