Multiple SclerosisNCT03684369
Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy
A study testing Transcutaneous electrical nerve stimulation in people with Multiple Sclerosis, run by University of Colorado, Boulder.
Trial summary
The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jun 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read, write, and speak English to ensure safe participation in the project
- Clinical diagnosis of multiple sclerosis
- Mild-to-moderate level of disability
- On stable doses of symptom-treating medications
- No MS exacerbations within the last 30 day
- Healthy enough to complete the protocol as indicated by the absence of a medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in tests that involve electrical nerve stimulation (e.g., not implanted devices or internal metal)
- Able to arrange own transportation to Boulder campus
Who cannot join
- Documented MS-related relapse within the last 30 days
- Medical diagnosis or condition that is considered to be a contraindication to participating in the intervention, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than basal cell cancer), other neurological disorders, or pregnancy.
- Vestibular disorder
- Musculoskeletal disorder
- History of seizure disorders
- >2 alcoholic drinks/day,or present history (last 6 months) of drug abuse
Show all 11Show fewer
- Spasticity that requires the individual to change an activity more than once a week
- Skin disease or sensation problems in the legs or hands that influence some activities more than once a week
- Claustrophobia
- Metallic implants
- Inability to attend treatment sessions 3 days per week for 6 weeks
About this study
The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.
Read the detailed description
The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.
- Conditions
- Multiple Sclerosis
- Being tested
- Transcutaneous electrical nerve stimulation
- Keywords
- walking, balance, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
Also called Sham transcutaneous electrical nerve stimulation
Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Augmented TENS | Experimental | Transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions. Receives: Device: Transcutaneous electrical nerve stimulation |
| Sham | Sham comparator | Transient (10 s) application of transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions . Receives: Device: Transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed
Time to walk 25 ft as quickly as possible
Measured: Change from baseline at weeks 4, 8, and 12.
Change in Walking Endurance
Distance walked in 6 min when walking at a brisk pace
Measured: Change from baseline at weeks 4, 8, and 12
Change in Dynamic Balance
Score achieved on the four components of the 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest). The maximum score for each subscale are: anticipatory = 6, reactive postural control = 6, sensory orientation = 6, dynamic gait = 10. The subscales are added to provide a total score with a maximum of 28.
Measured: Change from baseline at weeks 4, 8, and 12
Change in Patient Determined Disease Steps
A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden.
Measured: Change from baseline at weeks 4, 8, and 12
Change in Modified Fatigue Impact Scale
A questionnaire that assesses the impact of fatigue experienced by persons with MS. Each of the 21 items is rated from 0 = Never to 5 = Almost always. The maximum total score = 105
Measured: Change from baseline at weeks 4, 8, and 12.
Change in MS Walking Scale-12
A 12-item, patient-rated measure of how much MS compromises walking ability. Each item is rated from 1 = Not at all to 5 = extremely. The maximum total score = 60.
Measured: Change from baseline at weeks 4, 8, and 12.
Secondary outcomes (7)
Change in Romberg Quotient
Ratio of the total sway area when standing with the eyes closed relative to that when the eyes are open. The test will be performed while standing on a firm surface and a foam surface.
Measured: Change from baseline at weeks 4, 8, and 12.
Change Conditioned H-reflex Amplitude
Comparison of the percent reduction in the amplitude of the conditioned H-reflex amplitude in soleus while seated, standing with eyes open, and standing with eyes closed.
Measured: Change from baseline at weeks 4, 8, and 12.
Change in Proprioception Tract
Change in MRI signal intensity in corticospinal tract
Measured: Change from baseline at weeks 4, 8, and 12.
Change in Muscle Synergy Number
Non-negative matrix factorization will be used to identify the number of muscle synergies when subjects walk on a treadmill.
Measured: Change from baseline at weeks 4, 8, and 12
Change in Force Steadiness
The coefficient of variation for force when subjects perform steady, submaximal contractions.
Measured: Change from baseline at weeks 4, 8, and 12.
Change in Muscle Synergy TIming
The timing of the muscle synergies when subjects walk on a treadmill.
Measured: Change from baseline at weeks 4, 8, and 12.
Change in Discharge characteristics
The mean and coefficient of variation for the times between action potentials during steady isometric contractions.
Measured: Change from baseline at weeks 4, 8, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study startJul 2020 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: The project was not funded.
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Colorado State University
- Responsible party
- Principal investigator, Roger Enoka, University of Colorado, Boulder
- Investigators
- Roger Enoka, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684369
- Sponsor's protocol ID
- UColoradoBoulder2
- Status last verified
- Nov 2020
- First submitted
- 24 Aug 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the data obtained by individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy
- ClinicalTrials.gov ID
- NCT03684369
- Acronym / sponsor ID
- UColoradoBoulder2
- Conditions
- Multiple Sclerosis
- Keywords
- walking, balance, fatigue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Colorado State University
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 Sep 2018 (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.
The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.
Detailed description
The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented TENS | Experimental | Device: Transcutaneous electrical nerve stimulationTranscutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions. |
| Sham | Sham comparator | Device: Transcutaneous electrical nerve stimulationTransient (10 s) application of transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to read, write, and speak English to ensure safe participation in the project
- Clinical diagnosis of multiple sclerosis
- Mild-to-moderate level of disability
- On stable doses of symptom-treating medications
- No MS exacerbations within the last 30 day
Key exclusion criteria (11 listed)
- Documented MS-related relapse within the last 30 days
- Medical diagnosis or condition that is considered to be a contraindication to participating in the intervention, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than basal cell cancer), other neurological disorders, or pregnancy.
- Vestibular disorder
- Musculoskeletal disorder
- History of seizure disorders
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 nerve stimulationAlso: Sham transcutaneous electrical nerve stimulationCommercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions. | Device | Augmented TENS, Sham |
Primary outcome
Change in Gait Speed
Time frame: Change from baseline at weeks 4, 8, and 12.
Time to walk 25 ft as quickly as possible
Change in Walking Endurance
Time frame: Change from baseline at weeks 4, 8, and 12
Distance walked in 6 min when walking at a brisk pace
Change in Dynamic Balance
Time frame: Change from baseline at weeks 4, 8, and 12
Score achieved on the four components of the 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest). The maximum score for each subscale are: anticipatory = 6, reactive postural control = 6, sensory orientation = 6, dynamic gait = 10. The subscales are added to provide a total score with a maximum of 28.
Change in Patient Determined Disease Steps
Time frame: Change from baseline at weeks 4, 8, and 12
A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden.
Change in Modified Fatigue Impact Scale
Time frame: Change from baseline at weeks 4, 8, and 12.
A questionnaire that assesses the impact of fatigue experienced by persons with MS. Each of the 21 items is rated from 0 = Never to 5 = Almost always. The maximum total score = 105
Change in MS Walking Scale-12
Time frame: Change from baseline at weeks 4, 8, and 12.
A 12-item, patient-rated measure of how much MS compromises walking ability. Each item is rated from 1 = Not at all to 5 = extremely. The maximum total score = 60.
7 secondary outcomes
Change in Romberg Quotient
Time frame: Change from baseline at weeks 4, 8, and 12.
Change Conditioned H-reflex Amplitude
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Proprioception Tract
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Muscle Synergy Number
Time frame: Change from baseline at weeks 4, 8, and 12
Change in Force Steadiness
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Muscle Synergy TIming
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Discharge characteristics
Time frame: Change from baseline at weeks 4, 8, and 12.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No. There is no plan to share the data obtained by individual participants.
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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.
Roger Enoka, PhD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation in people with Multiple Sclerosis, run by University of Colorado, Boulder.
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 7 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: withdrawn, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Gait Speed (time frame: Change from baseline at weeks 4, 8, and 12.). The study lists 6 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 6 Nov 2020.