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New treatment option for Multiple Sclerosis
Official title Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
ClinicalTrials.gov ID: NCT06552611
What this study is testing
What is Transcutaneous electrical spinal cord stimulation + therapy?
Transcutaneous electrical spinal cord stimulation + therapy is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for multiple sclerosis.
Also referred to as Open-loop stimulation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70
You may be able to join if
- Diagnosis of MS
- Age between 21 and 70
- Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire),
- Ability to attend intervention and assessment sessions 3 times per week.
- For women of childbearing potential, willingness to provide confirmation of a negative over-the-counter home pregnancy test within 2 weeks of study...
You likely can't join if
- Relapse within the past 6 months (given that natural recovery from relapse could skew results)
- Active implanted stimulator or baclofen pump
- Upper extremity botox injection within the past 6 months
- Unstable dalfampridine usage during study duration (which may interfere with functional outcomes)
- Coexisting neurological condition that could interfere with interpretation of testing results (hx of stroke, traumatic brain injury...
- History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia
See the full eligibility criteria
- Diagnosis of MS
- Age between 21 and 70
- Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire),
- Ability to attend intervention and assessment sessions 3 times per week.
- 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.
- Relapse within the past 6 months (given that natural recovery from relapse could skew results)
- Active implanted stimulator or baclofen pump
- Upper extremity botox injection within the past 6 months
- Unstable dalfampridine usage during study duration (which may interfere with functional outcomes)
- 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...
- History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia
- Serious comorbidities (e.g., cardiac arrhythmia, uncontrolled hypertension, respiratory disease, cancer, renal failure, chronic infectious disease, rheumatic disease, frequent UTIs, etc.) that would prevent...
- 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
- Pregnant and/or breastfeeding
- Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment
- Inability to give consent
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.