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Behavioural Intervention

Electrical Stimulation + Therapy for Multiple Sclerosis

Phase 1

Recruiting

Led By Sarah Simmons, MD, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of MS

Ability to attend intervention and assessment sessions 3 times per week

Must not have

Upper extremity botox injection within the past 6 months

Unstable dalfampridine usage during study duration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment for adults with multiple sclerosis who have impaired upper extremity function. The treatment involves using electrical spinal cord stimulation along with occupational therapy to restore sensorimotor function.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here but may include discomfort or skin irritation from the electrodes used in spinal cord stimulation, as well as typical reactions to occupational therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple sclerosis (MS).

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I can attend sessions 3 times a week.

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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a botox injection in my arm within the last 6 months.

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I am not changing my dalfampridine dose during the study.

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I do not have a major psychiatric illness that could affect my treatment.

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My hand and arm have severe stiffness and cannot move properly.

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I may have difficulty understanding or following the study's procedures safely.

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I am unable to understand and give consent for treatment.

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I experience severe muscle stiffness or spasms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

NeuroQoL Upper Extremity Function

Nine-Hole Peg Test

Participant Drop-out rate

Secondary study objectives

Ability to Participate in Social Roles and Activities

Action Research Arm Test

Bladder Control Scale

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hand Therapy + StimulationExperimental Treatment2 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 aloneActive Control1 Intervention

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

0 / 10Eligibility criteria met