Electrical Stimulation + Therapy for Multiple Sclerosis

Overseen By Fatma Inanici, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Washington

Must not be taking: Botox, Dalfampridine

Disqualifiers: Neurological conditions, Psychiatric illness, Serious comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

4 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with multiple sclerosis (MS) improve hand and arm function. It combines electrical spinal cord stimulation, which uses gentle electric currents applied to the spine, with occupational therapy to determine if this combination is more effective than therapy alone. Participants will undergo both treatments for six weeks each, with a break in between. Those with MS who struggle with arm and hand use might be suitable candidates. The goal is to determine if this combined treatment improves daily life by alleviating symptoms like pain and muscle stiffness. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot participate if you have unstable dalfampridine usage during the study. It's best to discuss your current medications with the study team to see if they might affect your eligibility.

What prior data suggests that this electrical stimulation technique is safe for people with multiple sclerosis?

Earlier studies have shown that gentle electrical stimulation on the spinal cord is safe for people with spinal cord injuries. These studies found that the treatment improved hand and arm movement without causing serious side effects. Research also shows that this type of stimulation is practical and well-tolerated for aiding movement recovery. While researchers are now testing this treatment for a new use in multiple sclerosis, its previous use in other conditions suggests it is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using non-invasive electrical spinal cord stimulation for multiple sclerosis because it targets the nervous system directly without needing drugs. Unlike standard treatments like immunotherapy or corticosteroids, which aim to manage symptoms or slow disease progression, this approach potentially enhances neural connectivity and function through electrical signals. This innovative method could offer a new avenue for improving motor function, particularly in hand therapy, which is a promising development for patients seeking alternatives to medication-based treatments.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Research has shown that gentle electrical stimulation on the spinal cord can help people with spinal cord injuries improve upper body movement. In one study, 72% of participants experienced significant improvements in arm and hand use. Another study found that this stimulation also aided walking, as well as bladder, bowel, and sexual functions. Small pads placed on the skin deliver the stimulation, which is considered safe with no known side effects. In this trial, participants will receive either hand therapy alone or hand therapy combined with non-invasive electrical spinal cord stimulation. These findings suggest that the stimulation might also help people with multiple sclerosis improve arm and hand functions. ^{1 6 7 8 9}

Who Is on the Research Team?

Sarah Simmons, MD, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults with multiple sclerosis who have trouble with hand and arm functions. Participants will undergo two 6-week sessions of therapy, one combined with non-invasive spinal cord stimulation and one with just occupational therapy.

Inclusion Criteria

I have been diagnosed with multiple sclerosis (MS).

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

Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire)

Exclusion Criteria

Active implanted stimulator or baclofen pump

Coexisting neurological condition that could interfere with interpretation of testing results

Serious comorbidities that would prevent participation in study activities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment: Hand Therapy + Stimulation

Participants receive non-invasive transcutaneous electrical spinal cord stimulation paired with hand therapy sessions

6 weeks

3 visits per week (in-person)

Washout

A 6-week period with no intervention to allow for the effects of the first treatment to dissipate

6 weeks

Treatment: Hand Therapy alone

Participants undergo hand therapy sessions without spinal cord stimulation

6 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive Electrical Spinal Cord Stimulation

Trial Overview The study tests if adding electrical spinal cord stimulation to regular occupational therapy can better improve hand and arm function in MS patients than therapy alone. It's a pilot study, meaning it's an early test to see if the idea works well enough for more research.

How Is the Trial Designed?

Group I: Hand Therapy + Stimulation Experimental Treatment 2 Interventions

Participants will receive non-invasive transcutaneous electrical spinal cord stimulation paired with hand therapy sessions three times per week, 60 minutes per session, for six weeks.

Group II: Hand Therapy alone Active Control 1 Intervention

Participants randomized to hand therapy alone will participate in therapy sessions three times per week, 60 minutes per session for six weeks.

Non-invasive Electrical Spinal Cord Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Spinal Cord Stimulation for:

• Chronic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Diabetic peripheral neuropathy

Approved in European Union as Transcutaneous Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injuries

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

In a clinical trial involving 83 patients with chronic back pain, 88% reported significant pain relief after using a high-frequency spinal cord stimulation (SCS) system, with back pain scores dropping from an average of 8.4 to 2.7 after six months.

The high-frequency SCS system not only provided substantial pain relief without causing the tingling sensation (paresthesia) typical of traditional SCS but also improved patients' disability and sleep quality, confirming its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Van Buyten, JP., Al-Kaisy, A., Smet, I., et al.[2022]

Electrical stimulation significantly enhances the proliferation and differentiation of spinal cord-derived neural stem/progenitor cells (SC-NSPCs) in both in vitro and in vivo rodent models of spinal cord injury (SCI), leading to improved functional recovery.

The mechanism behind these benefits appears to involve the activation of the Wnt/β-catenin signaling pathway, suggesting that electrical stimulation could be a promising noninvasive treatment strategy for promoting neural regeneration after SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation promotes functional recovery after spinal cord injury by activating endogenous spinal cord-derived neural stem/progenitor cell: an in vitro and in vivo study. Bang, WS., Han, I., Mun, SA., et al.[2023]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

Electrical stimulation of the spinal cord has been explored as a treatment for multiple sclerosis, potentially offering new therapeutic options for managing symptoms.

The study discusses the physiological mechanisms behind how electrical fields can affect spinal cord function, which may lead to improved understanding and treatment strategies for multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional stimulation of the spinal cord in multiple sclerosis. Cook, AW., Taylor, JK., Nidzgorski, F.[2019]

Spinal cord stimulation (SCS) is generally a safe and effective treatment option, with complications being uncommon according to a comprehensive literature review.

The review emphasizes the importance of proper patient selection and adherence to evidence-based guidelines to minimize the risk of complications during SCS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and preventing complications in spinal cord stimulator implantation. Falowski, SM., Tan, H., Parks, J., et al.[2023]

Transcutaneous spinal direct current stimulation (tsDCS) has been shown to have dose-dependent effects on spinal and cortical excitability in healthy subjects, indicating its potential for modulating neural activity.

In a study involving nine healthy participants, both anodal and cathodal tsDCS demonstrated significant effects on motor evoked potentials and spinal cord excitability, suggesting that further research with larger samples could expand treatment options for spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationship of transcutaneous spinal direct current stimulation in healthy humans: A proof of concept study. Powell, ES., Korupolu, R., Westgate, PM., et al.[2019]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

In a study involving 49 multiple sclerosis patients, both electrical spinal cord stimulation and transcutaneous electrical stimulation led to significant subjective and objective improvements in bladder symptoms.

Transcutaneous electrical stimulation may serve as an effective preliminary treatment to identify patients who would benefit from subsequent electrical spinal cord stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation in multiple sclerosis. Comparison of transcutaneous electrical stimulation and epidural spinal cord stimulation. Fredriksen, TA., Bergmann, S., Hesselberg, JP., et al.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12412244/

Multi-system benefits of non-invasive spinal cord stimulation ... We investigated the effects of lumbosacral transcutaneous spinal cord stimulation (tSCS) on urinary bladder, bowel, and sexual function as well ...

2. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8068213/

Transcutaneous Spinal Cord Stimulation Enhances Walking ... Our results suggest that transcutaneous lumbar SCS can serve as a clinically accessible method without known side effects that holds the potential for ...

4. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(24)00111-9/fulltext

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

5. neurology.org neurology.org/doi/10.1212/CPJ.0000000000200537

Home-Based Noninvasive Spinal Cord Stimulation Safely ... Recently, the Up-LIFT Trial (NCT04697472) found that 72% of participants experienced clinically meaningful improvements in upper extremity ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924001119

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9966619/

First Use of Non-Invasive Spinal Cord Stimulation in Motor ... The feasibility of transcutaneous spinal cord stimulation (tSCS) in motor rehabilitation of patients with spinal cord injury has been demonstrated.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06587841

Noninvasive Spinal Cord Stimulation for Early SCI The purpose of this clinical study is to investigate the safety and effectiveness of non-surgical transcutaneous spinal cord stimulation (TSCS) in helping with ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Objective. Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) ...