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Active, not recruitingNCT07132775Updated Oct 20, 2026

Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain

An interventional study of Active full-body stimulation and Sham full-body stimulation in Multiple Sclerosis, Fibromyalgia and Neurologic Disorder, sponsored by Shirley Ryan AbilityLab. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment

Updated Oct 20, 2026Now Active, not recruitingGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,192 studies in Multiple Sclerosis with a site in United States — 184 open to participants now, 259 under way, 23 of them phase 3. Multiple Sclerosis · United States.

Planned enrollment
732nd of 879
15 · median 50
Started
2025
with 56 others
No phase
381 of 1,192
69 open now
Primary completion
2027-07
later than 132 of 256 live
Registered
1,123rd of 1,192
by date

Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 732nd largest by planned enrollment of the 879 interventional ones that give a count, is one of 57 that started in 2025, is one of 381 with no phase, reaches primary completion later than 132 of the 256 other live ones, and was the 1,123rd registered.

Multiple Sclerosis

3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

184 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now. Recruiting first, the newest first:

179 more — sign in →

All 184 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.

Read the detailed description

Optimization Aim: Identify a systematic, methodological approach to device fitting, in-clinic and at-home protocols using the Mollii suit, and optimization of collecting outcome measures at assessment visits. For example, up to 15 participants will complete a portion or all of the procedures listed in the "Procedures Involved" section of this protocol to determine an optimal approach.

Aim 1: Assess the safety of the Mollii suit during an in-clinic or at-home up to 12-week period consisting of up to daily sessions of a 60-minute duration in individuals with pain and/or spasticity from neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.

Aim 2: Evaluate the use of full-body active electrostimulation as compared to full-body sham electrostimulation as an intervention in-clinic or at-home for individuals experiencing pain and/or spasticity due to neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.

03

Conditions studied

  • Multiple Sclerosis
  • Fibromyalgia
  • Neurologic Disorder
  • Neuromuscular Disorders
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 75 years old
  2. Medical clearance from physician
  3. Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia
  4. For participants with a diagnosis of Multiple Sclerosis:

    1. having a definite diagnosis for at least one month
    2. Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) \< 7).
    3. Absence of relapses in the last three months
    4. Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS)
    5. Berg Balance Scale (BBS) score of ≤ 46 (associated in the literature with a risk of fall)
  5. For participants with a diagnosis of Fibromyalgia:

    a. having a definite diagnosis for at least three months

  6. Able to follow instructions and inform study staff of pain and/or discomfort
  7. Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance

Exclusion criteria

Exclusion Criteria:

  1. Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
  2. Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used
  3. No established somatic or neuropsychiatric diagnosis prior to enrollment in the study
  4. Pregnant and/or nursing
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Intervention

    Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters actively running.

    Device: Active full-body stimulation

  • Sham comparator
    Sham

    Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters not actively running.

    Other: Sham full-body stimulation

Interventions

  • DeviceActive full-body stimulation

    Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

  • OtherSham full-body stimulation

    Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

06

What researchers measure

Primary outcomes

  1. Berg Balance Scale

    The Berg Balance Scale is a 14-item objective measure that assesses static balance and falls risk. The functional abilities that are assessed include sitting and standing balance, transfers, altered bases of support, reaching, turning, and closing eyes.Scores range from 0 - 56, with higher scores indicating improved balance.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

Secondary outcomes

  1. Manual Muscle Test

    A procedure to evaluate the strength of individual muscles relative to gravity and manual resistance. Scores can range from 0 (no contraction) to 5 (full contraction against max resistance)

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  2. Modified Ashworth Scale

    The Modified Ashworth Scale is used to grade the amount of hypertonicity / spasticity in individuals. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. Scores can range from 0 (no spasticity) to 4 (affected part rigid.)

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  3. 10 Meter Walk Test

    Participants are timed as they walk 10 meters at both their self-selected speed, and their fastest but safest speeds.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  4. 6 Minute Walk Test

    A test to measure the distance that a participant can walk over a period of 6 minutes.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  5. Timed Up and Go

    The Timed Up and Go measures the time it takes for a person to stand up from a chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  6. Twelve-Item Multiple Sclerosis Walking Scale

    A self-report questionnaire that measures the impact of multiple sclerosis on a person's walking ability. Scores range from 12 - 60, with higher scores indicating a greater impact on walking ability.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  7. Falls Efficacy Scale

    A questionnaire that measures a participant's fear of falling for items related to activities of daily living. Scores range from 10 - 100, with higher scores indicating an increased fear of falling.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  8. Multiple Sclerosis International Quality of Life Questionnaire

    A multi-dimensional questionnaire about a patient's quality of life for those who have multiple sclerosis.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

  9. Clinical Global Impressions Scale

    A assessment of the clinician's view of a participant's global functioning prior to, and after initiating a study intervention.

    Time frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.

Of 848 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 24 months is close to that.

Counting every sponsor, half of 870 studies reached it within 21 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2025
First posted
Aug 20, 2025
StartActual
Jul 23, 2025
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07132775
Collaborators
Otto Bock Healthcare Products GmbH
Responsible party
Arun Jayaraman, PT, PhD (Director - Max Nader Center for Rehabilitation Technologies and Outcomes Research, Shirley Ryan AbilityLab) — Principal investigator
First posted
Aug 20, 2025
Start date
Jul 23, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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