Multiple SclerosisPhase 1NCT06552611
Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
A Phase 1 study testing Transcutaneous electrical spinal cord stimulation + therapy and Occupational Therapy in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Transcutaneous electrical spinal cord stimulation + therapy and Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2024to 1 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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, 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
Show all 12Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98133
Sarah Simmons, MD, PhD, sbs2@uw.edu
Fatma Inanici, MD, PhD
About this study
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.
Read more
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:
- transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants
- transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone
- 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
- Conditions
- Multiple Sclerosis
- Being tested
- Transcutaneous electrical spinal cord stimulation + therapy, Occupational Therapy
- Keywords
- Rehabilitation, Neuromodulation, Spinal Cord stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical spinal cord stimulation + therapyCombination product
Also called Open-loop stimulation
A two-channel transcutaneous spinal cord stimulator (SCONE, SpineX, Inc.) will deliver non-invasive electrical stimulation during hand therapy 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 as cathodes to stimulate the cervical spinal cord at two vertebral levels. An additional pair of electrodes will be symmetrically positioned over either the iliac crests or shoulders, functioning as anodes. 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 range from 0 to 120 milliamperes (mA), with incremental increases of 5 mA until reaching the level that facilitates voluntary movement. The stimulation amplitude will be fine-tuned for each specific activity based on the therapist's observation.
Occupational TherapyOther
Also called hand therapy, functional task practice
The hand therapy 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. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each training session. Activities are chosen according to the participant's ability, interests, and needs and are modified as function progresses over time.
| Study group | Role | What they receive |
|---|---|---|
| Hand Therapy alone | Active comparator | Participants randomized to hand therapy alone will participate in therapy sessions three times per week, 60 minutes per session for six weeks. Receives: Other: Occupational Therapy |
| Hand Therapy + Stimulation | Experimental | 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. Receives: Combination Product: Transcutaneous electrical spinal cord stimulation + therapy; Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine-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: 6 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: 6 weeks
Participant Drop-out rate
Percentage of participants who complete the intervention protocol. (0-100%)
Measured: 6 weeks
Secondary outcomes (13)
Action Research 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. Scores are aggregated to a final scale (ranging from 0-57); Higher scores indicate better performance.
Measured: 6 weeks
Box and 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. Score ranges from 0-150; higher score indicates better function.
Measured: 6 weeks
Grip force
measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-200); higher score indicates better function.
Measured: 6 weeks
Pinch force
measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-100); higher score indicates better function.
Measured: 6 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). Higher score indicates worse function
Measured: 6 weeks
Patient-reported Impact of Spasticity Measure
A patient-reported outcome questionnaire assessing the impact of spasticity on function and quality of life over the past week. Score ranges from 0-164; higher scores indicate worse function.
Measured: 6 weeks
Modified Fatigue Impact Scale
A patient-reported outcome questionnaire. It is a modified form of the Fatigue Impact Scale based on items derived from interviews with multiple sclerosis patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue on physical, cognitive, and psychosocial functioning. Score ranges from 0-84; higher score indicates worse function.
Measured: 6 weeks
PROMIS Pain Interference
A patient-reported outcome questionnaire that measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Score ranges from 4-20; higher score indicates worse function.
Measured: 6 weeks
PROMIS Pain Intensity
A patient-reported outcome numeric rating scale of pain over the past 7 days. Score ranges from0-10; higher score indicates worse pain
Measured: 6 weeks
Bowel Control Scale
A patient-reported outcome questionnaire for bowel management. This is a subsection of the Multiple Sclerosis Quality of Life Inventory. Score ranges from 0-26; higher score indicates worse function.
Measured: 6 weeks
Bladder Control Scale
A patient-reported outcome questionnaire for bladder management. This is a subsection of the Multiple Sclerosis Quality of Life Inventory. Score ranges from 0-22; higher score indicates worse function.
Measured: 6 weeks
Global Impression of Change
A patient and clinician-reported scale of change pre- to post-intervention, ranging from 1 (indicating "very much improved") to 7 (indicating "very much worse").
Measured: 6 weeks
Ability to Participate in Social Roles and Activities
A self-report of health-related quality of life in 17 domains and sub-domains for adults with neurological disorders. Score ranges from 4-40; higher scores indicates better function.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start8 Aug 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, open-label, two-intervention arm cross-over clinical trial of transcutaneous spinal cord stimulation combined with therapy compared to therapy alone in four adults with MS and upper extremity impairment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 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
- NCT06552611
- Sponsor's protocol ID
- STUDY00020787
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06552611
- Acronym / sponsor ID
- STUDY00020787
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Neuromodulation, Spinal Cord stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 14 Aug 2024 (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.
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:
- transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants
- transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, open-label, two-intervention arm cross-over clinical trial of transcutaneous spinal cord stimulation combined with therapy compared to therapy alone in four adults with MS and upper extremity impairment.
| Arm | Type | Receives |
|---|---|---|
| Hand Therapy alone | Active comparator | Other: Occupational TherapyParticipants randomized to hand therapy alone will participate in therapy sessions three times per week, 60 minutes per session for six weeks. |
| Hand Therapy + Stimulation | Experimental | Combination Product: Transcutaneous electrical spinal cord stimulation + therapy, Other: Occupational TherapyParticipants 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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, intracranial tumor, intracranial aneurysm, cervical myelopathy/radiculopathy or peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy), etc.)
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 |
|---|---|---|
| Transcutaneous electrical spinal cord stimulation + therapyAlso: Open-loop stimulationA two-channel transcutaneous spinal cord stimulator (SCONE, SpineX, Inc.) will deliver non-invasive electrical stimulation during hand therapy 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 as cathodes to stimulate the cervical spinal cord at two vertebral levels. An additional pair of electrodes will be symmetrically positioned over either the iliac crests or shoulders, functioning as anodes. 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 range from 0 to 120 milliamperes (mA), with incremental increases of 5 mA until reaching the level that facilitates voluntary movement. The stimulation amplitude will be fine-tuned for each specific activity based on the therapist's observation. | Combination product | Hand Therapy + Stimulation |
| Occupational TherapyAlso: hand therapy, functional task practiceThe hand therapy 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. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each training session. Activities are chosen according to the participant's ability, interests, and needs and are modified as function progresses over time. | Other | Hand Therapy + Stimulation, Hand Therapy alone |
Primary outcome
Nine-Hole Peg Test
Time frame: 6 weeks
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.
NeuroQoL Upper Extremity Function
Time frame: 6 weeks
A self-report of health-related quality of life for adults with neurological disorders. Score ranges from 8-40; higher score = better function
Participant Drop-out rate
Time frame: 6 weeks
Percentage of participants who complete the intervention protocol. (0-100%)
13 secondary outcomes
Action Research Arm Test
Time frame: 6 weeks
Box and Blocks Test
Time frame: 6 weeks
Grip force
Time frame: 6 weeks
Pinch force
Time frame: 6 weeks
Modified Ashworth Scale
Time frame: 6 weeks
Patient-reported Impact of Spasticity Measure
Time frame: 6 weeks
Modified Fatigue Impact Scale
Time frame: 6 weeks
PROMIS Pain Interference
Time frame: 6 weeks
PROMIS Pain Intensity
Time frame: 6 weeks
Bowel Control Scale
Time frame: 6 weeks
Bladder Control Scale
Time frame: 6 weeks
Global Impression of Change
Time frame: 6 weeks
Ability to Participate in Social Roles and Activities
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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. This study is not recruiting at the moment.
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 Phase 1 study testing Transcutaneous electrical spinal cord stimulation + therapy and Occupational Therapy 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Simmons, MD, PhD (206-356-6352, sbs2@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine-Hole Peg Test (time frame: 6 weeks). The study lists 3 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 14 Aug 2024.