Home-based Spinal Cord Stimulation for Hand & Arm Function in MS

Official title

Transcutaneous Spinal Cord Stimulation for Recovery of Hand and Arm Function in Multiple Sclerosis: A Home-Based Study

Overview

This is a pilot study designed to test the feasibility of in-home, non-invasive (transcutaneous, applied by surface electrodes over the skin) electrical spinal cord stimulation combined with exercises for restoring upper extremity sensorimotor function in adults with multiple sclerosis. Participants with multiple sclerosis and impaired upper extremity function will complete 8-weeks of hand/arm exercises combined with spinal cord stimulation performed at home with the help of a partner. The investigators hypothesize that: 1. in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will be feasible and acceptable by participants 2. in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will lead to improvements in upper extremity function after 8-weeks 3. in-home transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life (pain, spasticity, and bladder symptoms)

Interventions

• Combination product Spinal Cord Stimulation + Hand/arm Exercises
  A two-channel transcutaneous spinal cord stimulator (SCONE, SpineX, Inc.) will deliver non-invasive electrical stimulation during hand/arm exercise sessions. For each session, two self-adhesive hydrogel electrodes will be positioned along the midline of the C3-C4 and C6-C7 spinous processes over the skin. The electrical current employed for the transcutaneous spinal cord stimulation is biphasic, featuring a 1-millisecond pulse width, a base frequency of 30 Hz, and an overlapping frequency of 10

Primary outcome measures

• Retention rate [Time frame: 8 weeks]
• Acceptability of intervention [Time frame: 8 weeks]

Secondary outcome measures (6)

• 9-hole PEG Test [Time frame: 8 weeks]
• Action Reach Arm Test [Time frame: 8 weeks]
• Box & Blocks Test [Time frame: 8 weeks]
• Modified Ashworth Scale [Time frame: 8 weeks]
• • NeuroQoL Upper Extremity Function [Time frame: 8 weeks]
• Pinch & Grip Force [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• Diagnosis of multiple sclerosis
• Adult individuals between 18 and 70 years of age.
• Impaired upper extremity function as evidenced by 9-Hole Peg Test >33.5 sec
• Partner or caregiver willing to provide support during intervention
• Ability to give consent
• For women of childbearing potential, willingness to provide confirmation of a negative over-the-counter home pregnancy test within 2 weeks of study entry and prior to each intervention arm. They must also be willing to practice adequate contraception (which may include implant, intrauterine device (IUD), injection, pill, patch, vaginal ring, or diaphragm) during the study period.

Exclusion criteria

• Multiple sclerosis relapse within the past 3 months (given that natural recovery from MS relapse could skew results)
• History of seizure, active implanted stimulator (pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
• Upper extremity Botox injection within the past 4 months
• Coexisting neurological condition that could interfere with interpretation of testing results (hx of stroke, traumatic brain injury, epilepsy/seizure, ALS, spinal cord injury, central nervous system vasculitis, intracranial tumor, intracranial aneurysm, cervical myelopathy/radiculopathy or peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy), etc.),
• History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia.
• Contraindication to transcranial magnetic stimulation
• Serious comorbidities (e.g., cardiac arrhythmia, uncontrolled hypertension, respiratory disease, cancer, renal failure, chronic infectious disease, rheumatic disease, frequent UTIs, etc.) that would prevent participation in study activities,
• Presence of severe joint contractures in the affected hand and arm that may interfere with study activities or outcome measures,
• Severe spasticity, as defined by an Ashworth score of 4 in both sides of the upper limb
• Pregnancy and breastfeeding (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation whether they could be pregnant. Pregnancy will be ruled out by home over-the-counter urine pregnancy tests for all females of childbearing potential (1) at the time of enrollment and (2) at the beginning of intervention arms. Additional pregnancy tests may be performed if there is concern about pregnancy.)
• Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Washington — Seattle

Identifiers

NCT: NCT07673354 · STUDY00024536

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗