Multiple SclerosisNCT02152085
Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
A study testing Narrow pulse and Wide pulse in people with Multiple Sclerosis, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Narrow pulse and Wide pulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to read, understand, and speak English to ensure safe participation in the project
- Difficulties with walking
- On stable doses of Ampyra, provigil, or other symptomatic-treating medications
- No systemic steroids within the last 30 days
- Not currently exercising more than 2x/wk
- Able to arrange own transportation to and from the laboratories
- Provide informed consent, including willingness to be randomly assigned to one of the two groups
Who cannot join
- Documented MS-related relapse in the last 3 months
- Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
- Poorly controlled diabetes mellitus or hypertension
- History of seizure disorders
- Alcohol dependence or abuse (≥2 drinks/day), or present history (last 6 months) of drug abuse
- Inability to attend exercise sessions 3 days per week for 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.
Read the detailed description
Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.
- Conditions
- Multiple Sclerosis
- Being tested
- Narrow pulse, Wide pulse
- Keywords
- Walking, Mobility, Neuromuscular electrical stimulation, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow pulseDevice
Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
Wide pulseDevice
Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
| Study group | Role | What they receive |
|---|---|---|
| Narrow pulse | Experimental | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms. Receives: Device: Narrow pulse |
| Wide pulse | Experimental | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms. Receives: Device: Wide pulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Endurance
Distance walked in 6 min
Measured: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Modified Fatigue Impact Scale
MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.
Measured: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Secondary outcomes (1)
Maximal Walking Speed
The time it takes to walk 25 ft
Measured: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Roger Enoka, University of Colorado, Boulder
- Investigators
- Roger Enoka, PhD, Principal investigator, University of Colorado, BoulderJeffrey Hebert, PhD, PT, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152085
- Sponsor's protocol ID
- 13-0720
- Other IDs
- R03HD079508
- Status last verified
- May 2021
- First submitted
- 16 May 2014
- Last updated
- 7 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02152085
- Acronym / sponsor ID
- 13-0720
- Conditions
- Multiple Sclerosis
- Keywords
- Walking, Mobility, Neuromuscular electrical stimulation, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Posted 7 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.
Detailed description
Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow pulse | Experimental | Device: Narrow pulseSix-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms. |
| Wide pulse | Experimental | Device: Wide pulseSix-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able to read, understand, and speak English to ensure safe participation in the project
- Difficulties with walking
- On stable doses of Ampyra, provigil, or other symptomatic-treating medications
- No systemic steroids within the last 30 days
- Not currently exercising more than 2x/wk
Key exclusion criteria (6 listed)
- Documented MS-related relapse in the last 3 months
- Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
- Poorly controlled diabetes mellitus or hypertension
- History of seizure disorders
- Alcohol dependence or abuse (≥2 drinks/day), or present history (last 6 months) of drug abuse
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 |
|---|---|---|
| Narrow pulseParticipants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses. | Device | Narrow pulse |
| Wide pulseParticipants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses. | Device | Wide pulse |
Primary outcome
Walking Endurance
Time frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Distance walked in 6 min
Modified Fatigue Impact Scale
Time frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.
1 secondary outcome
Maximal Walking Speed
Time frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Boulder
Jeffrey Hebert, PhD, PT principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow pulse and Wide pulse in people with Multiple Sclerosis, run by University of Colorado, Boulder 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 7 May 2021. 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?
Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Walking Endurance (time frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).). 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 7 May 2021.