Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke

Overview

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.

Interventions

• Device Non-invasive Electrical Spinal Cord Stimulation
  Electrical stimulation of the spinal cord using surface electrodes
• Other Activity Based Rehabilitation
  Exercise therapy targeting paralyzed hand and arm

Primary outcome measures

• Change from baseline - Fugl-Meyer assessment of the upper limb [Time frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."]
• Change from baseline - Pinch and grip force [Time frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."]
• Change from baseline - Modified Ashworth Scale [Time frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."]
• Change from baseline - Wolf Motor Function Test [Time frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."]

Secondary outcome measures (9)

• Change from baseline - Action Research Arm Test [Time frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."]
• Change from baseline - Box and Blocks Test [Time frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."]
• Change from baseline - Revised Nottingham Sensory Assessment [Time frame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."]
• Change from baseline - Stroke Impact Scale [Time frame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."]
• Change from baseline - Short Form-36 [Time frame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."]
• Change from baseline - Patients Global Impression of Change [Time frame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."]
• Change from baseline - H-reflex test [Time frame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."]
• Change from baseline - Somatosensory evoked potentials test [Time frame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."]
• Change from baseline - Spinally evoked motor potentials test [Time frame: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Washington — Seattle

Identifiers

NCT: NCT05591196 · STUDY00015990

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗