Secondary Progressive Multiple SclerosisNCT01647321
Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis
A study testing Active cycling and Passive cycling in people with Secondary Progressive Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with… Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- What is being tested?
- Active cycling and Passive cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2019
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of secondary progressive multiple sclerosis
- males and females between the ages of 18 and 65 years
- Expanded disability status scale score between 5.0 and 7.0
- Able to consent to participate in study and are willing to undergo a lumbar puncture and blood draws
- If on on Ampyra or anti-spasticity agent, must be on stable dose for 1 month prior to screening
- No functional electrical stimulation use within 4 weeks
- Participants must be medically stable with no recent (1 month or less) inpatient admission for acute medical or surgical issues
Who cannot join
- Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
- History of epileptic seizures
- Subjects who have a pacemaker
- Relapse within thirty days prior to screening visit
- Pregnancy
- Subjects having a Stage 2 or greater sacral decubitus ulcer
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins / Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
Official title: Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis
Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling will improve walking in subjects with SPMS.
Read the detailed description
Individuals with secondary progressive multiple sclerosis (SPMS) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. Treatment attempts for progressive MS have been disappointing. No therapeutic intervention has been shown to modulate disability in patients with SPMS. FES cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory central nervous system (CNS) environment in progressive MS. The investigators are proposing a novel, and easy to implement intervention strategy of FES cycling to help improve gait function in individuals with SPMS. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. FES is easily transferable to clinical practice and could potentially ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost. In addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Being tested
- Active cycling, Passive cycling
- Keywords
- SPMS
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cyclingBehavioural
Also called cycling, endurance training
The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to actively pedal while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
Passive cyclingBehavioural
Also called letting the functional electrical stimulation move the legs
The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to sit passively on the stationary bile while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active cycling | Active comparator | Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal. Receives: Behavioral: Active cycling |
| Passive cycling | Sham comparator | Individuals will receive active functional electrical stimulation (FES) while on the stationary bike and instructed to relax their legs, allowing the FES to move their legs on the stationary bike. Receives: Behavioral: Passive cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in timed 25 foot walk from baseline to end of training
Here we will assess whether a subjects walking speed is improved following active cycling with functional electrical stimulation. Our prediction is that individuals will improve in their walking function following seated active cycling with functional electrical stimulation.
Measured: Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Responsible party
- Sponsor
- Investigators
- Scott Newsome, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647321
- Sponsor's protocol ID
- NA_00069253
- Status last verified
- Mar 2020
- First submitted
- 19 Jul 2012
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01647321
- Acronym / sponsor ID
- NA_00069253
- Conditions
- Secondary Progressive Multiple Sclerosis
- Keywords
- SPMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study start
- Jul 2012 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 23 Jul 2012 (estimated)
- 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.
Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling will improve walking in subjects with SPMS.
Detailed description
Individuals with secondary progressive multiple sclerosis (SPMS) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. Treatment attempts for progressive MS have been disappointing. No therapeutic intervention has been shown to modulate disability in patients with SPMS. FES cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory central nervous system (CNS) environment in progressive MS. The investigators are proposing a novel, and easy to implement intervention strategy of FES cycling to help improve gait function in individuals with SPMS. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. FES is easily transferable to clinical practice and could potentially ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost. In addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cycling | Active comparator | Behavioral: Active cyclingIndividuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal. |
| Passive cycling | Sham comparator | Behavioral: Passive cyclingIndividuals will receive active functional electrical stimulation (FES) while on the stationary bike and instructed to relax their legs, allowing the FES to move their legs on the stationary bike. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinical diagnosis of secondary progressive multiple sclerosis
- males and females between the ages of 18 and 65 years
- Expanded disability status scale score between 5.0 and 7.0
- Able to consent to participate in study and are willing to undergo a lumbar puncture and blood draws
- If on on Ampyra or anti-spasticity agent, must be on stable dose for 1 month prior to screening
Key exclusion criteria (6 listed)
- Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
- History of epileptic seizures
- Subjects who have a pacemaker
- Relapse within thirty days prior to screening visit
- Pregnancy
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 |
|---|---|---|
| Active cyclingAlso: cycling, endurance trainingThe exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to actively pedal while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks. | Behavioural | Active cycling |
| Passive cyclingAlso: letting the functional electrical stimulation move the legsThe exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to sit passively on the stationary bile while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks. | Behavioural | Passive cycling |
Primary outcome
Change in timed 25 foot walk from baseline to end of training
Time frame: Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)
Here we will assess whether a subjects walking speed is improved following active cycling with functional electrical stimulation. Our prediction is that individuals will improve in their walking function following seated active cycling with functional electrical stimulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- 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. This study is not recruiting at the moment.
Scott Newsome, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycling and Passive cycling in people with Secondary Progressive Multiple Sclerosis, run by Johns Hopkins University 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 19 Mar 2020. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 timed 25 foot walk from baseline to end of training (time frame: Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)). 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 19 Mar 2020.