Multiple SclerosiseSTIM-MS HomeNCT07673354
Home-based Spinal Cord Stimulation for Hand & Arm Function in MS
A study testing Spinal Cord Stimulation + Hand/arm Exercises in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Spinal Cord Stimulation + Hand/arm Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transcutaneous Spinal Cord Stimulation for Recovery of Hand and Arm Function in Multiple Sclerosis: A Home-Based Study
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.
Read more
The investigators hypothesize that:
- in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will be feasible and acceptable by participants
- in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will lead to improvements in upper extremity function after 8-weeks
- 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)
- Conditions
- Multiple Sclerosis
- Being tested
- Spinal Cord Stimulation + Hand/arm Exercises
- Keywords
- spinal cord stimulation, neuromodulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation + Hand/arm ExercisesCombination product
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 kHz. Stimulation intensity will be individualized for each participant, up to a maximum of 120 milliamperes (mA). The hand/arm exercise program is comprised of intensive, progressive, functional task practice following a standardized protocol. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise + Spinal Cord Stimulation | Experimental | The 8-week intervention will consist of approximately 1-hour sessions, 3-4x times per week. These sessions will occur in the participant's home, during which hand/arm exercises and transcutaneous spinal cord stimulation (tSCS) will be performed. A caregiver or partner will assist with electrode placement and tSCS administration. Exercises are similar to what would be prescribed by an occupational therapist for an outpatient home exercise program, and include: repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. Receives: Combination Product: Spinal Cord Stimulation + Hand/arm Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Percentage of participants who complete the intervention protocol. (0-100%)
Measured: 8 weeks
Acceptability of intervention
a questionnaire with 7 multiple choice questions on a 5-point Likert scale, and one open-ended comment section designed to assess participant's acceptability and tolerability of transcutaneous spinal cord stimulation.
Measured: 8 weeks
Secondary outcomes (6)
9-hole PEG Test
Nine-Hole Peg Test is a standardized, quantitative assessment used to measure finger dexterity. Score is time it takes to complete task (range 15-180 seconds). Higher score = worse outcome.
Measured: 8 weeks
Action Reach Arm Test
A 19-item clinician-administered observational measure to assess upper extremity performance (coordination, dexterity, and functioning). Items comprising the ARAT are categorized into four subscales (grasp: 6 items, score 0-18; grip: 4 items, score 0-12; pinch: 6 items, score 0-18; and gross movement: 3 items, score 0-9) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Higher scores indicate better performance.
Measured: 8 weeks
Box & Blocks Test
Measures unilateral gross manual dexterity. The test kit comprises a wooden box divided into two compartments by a partition and 150 blocks. Participants move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds
Measured: 8 weeks
Modified Ashworth Scale
A clinician-administered test for resistance of a joint to the passive movement. This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity).
Measured: 8 weeks
• NeuroQoL Upper Extremity Function
A self-report of health-related quality of life for adults with neurological disorders. Score ranges from 8-40; higher score = better function
Measured: 8 weeks
Pinch & Grip Force
measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-100); higher score indicates better function.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start16 Jul 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Simmons, MD, PhD, University of Washington
- Investigators
- Sarah Simmons, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673354
- Sponsor's protocol ID
- STUDY00024536
- Acronym
- eSTIM-MS Home
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation for Recovery of Hand and Arm Function in Multiple Sclerosis: A Home-Based Study
- ClinicalTrials.gov ID
- NCT07673354
- Acronym / sponsor ID
- eSTIM-MS Home / STUDY00024536
- Conditions
- Multiple Sclerosis
- Keywords
- spinal cord stimulation, neuromodulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 16 Jul 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will be feasible and acceptable by participants
- in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will lead to improvements in upper extremity function after 8-weeks
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Exercise + Spinal Cord Stimulation | Experimental | Combination Product: Spinal Cord Stimulation + Hand/arm ExercisesThe 8-week intervention will consist of approximately 1-hour sessions, 3-4x times per week. These sessions will occur in the participant's home, during which hand/arm exercises and transcutaneous spinal cord stimulation (tSCS) will be performed. A caregiver or partner will assist with electrode placement and tSCS administration. Exercises are similar to what would be prescribed by an occupational therapist for an outpatient home exercise program, and include: repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Stimulation + Hand/arm ExercisesA 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 kHz. Stimulation intensity will be individualized for each participant, up to a maximum of 120 milliamperes (mA). The hand/arm exercise program is comprised of intensive, progressive, functional task practice following a standardized protocol. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. | Combination product | Home Exercise + Spinal Cord Stimulation |
Primary outcome
Retention rate
Time frame: 8 weeks
Percentage of participants who complete the intervention protocol. (0-100%)
Acceptability of intervention
Time frame: 8 weeks
a questionnaire with 7 multiple choice questions on a 5-point Likert scale, and one open-ended comment section designed to assess participant's acceptability and tolerability of transcutaneous spinal cord stimulation.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Simmons, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation + Hand/arm Exercises in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.