Status unknownPhase 1MS (type not specified)NCT06552611

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Transcutaneous electrical spinal cord stimulation + therapy
  • Occupational Therapy

What it measured

Main measures

  • Nine-Hole Peg Test

    6 weeks

    Arm and hand function
  • NeuroQoL Upper Extremity Function

    6 weeks

    Arm and hand functionQuality of life (reported by participants)
  • Participant Drop-out rate

    6 weeks

Other measures (13)

  • Action Research Arm Test

    6 weeks

    Arm and hand function
  • Box and Blocks Test

    6 weeks

    Arm and hand function
  • Grip force

    6 weeks

    Arm and hand functionPhysical function
  • Pinch force

    6 weeks

    Physical function
  • Modified Ashworth Scale

    6 weeks

    Spasticity
  • Patient-reported Impact of Spasticity Measure

    6 weeks

    SpasticityQuality of life (reported by participants)
  • Modified Fatigue Impact Scale

    6 weeks

    Thinking and memoryFatigueQuality of life (reported by participants)
  • PROMIS Pain Interference

    6 weeks

    Thinking and memoryPainQuality of life (reported by participants)
  • PROMIS Pain Intensity

    6 weeks

    PainQuality of life (reported by participants)
  • Bowel Control Scale

    6 weeks

    Bladder, bowel and sexual functionQuality of life (reported by participants)

Who could take part

MS (type not specified) · 21 to 70

Inclusion Criteria: 1. Diagnosis of MS 2. Age between 21 and 70 3. Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire), 4. Ability to attend intervention and assessment sessions 3 times per week. 5. 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. Exclusion Criteria: 1. Relapse within the past 6 months (given that natural recovery from relapse could skew results) 2. Active implanted stimulator or baclofen pump 3. Upper extremity botox injection within the past 6 months 4. Unstable dalfampridine usage during study duration (which may interfere with functional outcomes) 5. 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.) 6. History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia 7. 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 8. Presence of severe joint contractures in the affected hand and arm that may interfere with study activities or outcome measures 9. Severe spasticity, as defined by an Ashworth score of 4 in both sides of the upper limb 10. Pregnant and/or breastfeeding 11. Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment 12. Inability to give consent

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Current disease-modifying therapies for multiple sclerosis (MS) aim to prevent the development of new lesions; unfortunately, no current FDA-approved therapies promote central nervous system (CNS) repair mechanisms. Thus, strategies to promote functional recovery from lesion-related deficits in adults with MS remain an unmet need. This is a pilot study designed to test the feasibility, safety and preliminary efficacy of non-invasive (transcutaneous, applied by surface electrodes over the skin) electrical spinal cord stimulation combined with occupational therapy for restoring upper extremity sensorimotor function in adults with multiple sclerosis. Participants with multiple sclerosis and impaired upper extremity function will complete two separate 6-week intervention sessions: 6 weeks of occupational therapy combined with transcutaneous spinal cord stimulation and 6 weeks of occupational therapy alone. The order of these interventions will be randomized, and each intervention will be separated by a 6-week washout period. The investigators hypothesize that: 1. transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants 2. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone 3. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life (pain, spasticity, and bladder symptoms) compared to occupational therapy alone

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History

    1. Started

      Aug 2024

    2. Main results due

      Jul 2025

    3. Finished

      Jul 2025

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