Multiple SclerosisremappingNCT01816100
The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients
A study testing specifically design 6 month resistance training program and 6 months weight resistance and balance program in people with Multiple Sclerosis, run by University of Nebraska at 1 site in United States.
Trial summary
This study is a unique blend of new technologies never used in combination with individuals diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in brain activity, functional brain activation and diffusion in the brain following 6 months of structured weight resistance and balance… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- specifically design 6 month resistance training program and 6 months weight resistance and balance program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2013to 1 Sep 2015
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of relapsing/remitting or secondary progressive MS by McDonald Criteria (for patient groups)
- Competent to give informed consent.
- ≥ 19 years and <65 years of age.
- EDSS score <7.0 and able to walk 25 feet with or without a cane.
- Willingness to comply with the evaluation schedule for the study. This includes participation in a bi-weekly standardized structured resistance training and separate data collections done at each time point (baseline and 3 months).
- Evidence that the MS patient's physical and neurological examinations are "clinically acceptable." Clinically acceptable is defined as those clinical findings or conditions that would not place the patient in undue risk by participating and which would not interfere with outcome measures of the study.
Who cannot join
- Unable to give informed consent.
- Unable or unwilling to sign safety waiver.
- EDSS score ≥7 or are unable to walk 25 feet with the use of a cane
- Unwilling or unable to complete the exercise program and other aspects of the study (e.g., not keeping appointments, lack of active participation in the exercise sessions, or displaying inability to follow instructions allowing appropriate exercise advancement).
- Pregnant, breastfeeding or within 3 months post partum at initiation of study.
- Have any other disability that would affect balance and/or mobility.
Show all 9Show fewer
- Have any other neurological or neurodegenerative disorders.
- Have any other conditions, clinical findings or reason that deems the subject unsuitable for enrollment into the study.
- Have an implantable device or history of metal in body.
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients: A Multimodal Neuroimaging Investigation
This study is a unique blend of new technologies never used in combination with individuals diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in brain activity, functional brain activation and diffusion in the brain following 6 months of structured weight resistance and balance training. Positive changes would indicate that the therapy has ignited brain plasticity and may drive the brain to repair itself. These changes to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and slowing of neural degeneration. No other trials have been published evaluating brain plasticity utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in subjects with MS undergoing physical training. DTI has demonstrated the ability to find changes (plasticity) that occur in the brain and using the MEG findings to focus the DTI analysis will optimize the capacity to detect changes secondary to therapy. This quantification will give a better understanding of the repair that goes on in the brain, and may potentially revolutionize the field of the central nervous system (CNS) rehabilitation. One of the most innovative aspects of this study is the full integration of clinical neurobehavioral metrics and functional imaging data in conjunction with a proven MS therapy along with quality of life indicators. This approach will allow new links to be illuminated as the trajectories of functional and structural brain changes (neuroplasticity) are meshed with clinical improvement indices collected visit-by-visit. This study will also compare disease modifying treatments (DMTs) and their effect(s) on indices of brain plasticity and cognitive and behavioral assessments.
Read the detailed description
Rationale MEG is a direct measure of ongoing neurophysiological activity and is appropriate because of spatiotemporal resolution of measurements and immunity of the technique to vascular biases that contaminate functional MRI imaging of MS patients.4 MEG will help to illuminate the brain bases of motor deficits that exist relative to healthy controls and show how the improvements observed behaviorally are reflected in the brain activity that underlies those improvements. Since DTI has demonstrated the ability to find changes (plasticity) that occur in the brain in patients, it is very promising that DTI will be able to detect evidence of neuroplasticity in our research population.5 Using the MEG findings to sharpen the DTI analysis, a very powerful combination, will optimize the ability to detect and understand changes.
Objectives Specific Aim 1 - Determine if there are activation differences (see below) in the neural regions serving motor function during basic movements using MEG in a group of MS patients, comparing MS affected portions of the brain versus non-affected.
Specific Aim 2 - Determine the effect of a specific 6 month resistance and balance exercise program on activation in sensorimotor brain areas using MEG, and correlate changes in these neural indices with those of specific movement and balance.
Specific Aim 3 - Determine the effect of a specific 6 month resistance and balance exercise program on brain diffusivity and fractional anisotropy using DTI and correlate changes in these metrics with improvement in strength and balance measures in subjects with MS, comparing MS affected portions of the brain versus non-affected areas..
Specific Aim 4 - Determine whether increased fiber integrity (fractional anisotropy) along the corticospinal tract is reflected in MEG activation metrics of the primary motor cortex from baseline to 6 months in subjects with MS enrolled in the three-month resistance and balance exercise program.
- Conditions
- Multiple Sclerosis
- Being tested
- specifically design 6 month resistance training program, 6 months weight resistance and balance program
- Keywords
- multiple sclerosis, exercise, MEG, DTI, Brain changes
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specifically design 6 month resistance training programOther
Also called 6 months weight resistance session,
Data will be kept on the number of repetitions and amount of weight per exercise session See intervention description
6 months weight resistance and balance programBehavioural
Also called 50-minute, biweekly sessions for 6 months
3 phases first phase-strength improvement using stationary machines second phase-time is divided between stationary machines, balance, dexterity third phase-free weight movements
| Study group | Role | What they receive |
|---|---|---|
| exercise session | Experimental | 6 months weight resistance session, with before/after evaluations by MEG and DTI. Fifty minute exercise sessions, twice weekly will be done. Each session will rotate between 3 separate exercise protocols: Static weights, free weights and balance. Exercises will be done with each extremity independently. For consistency and convenience, the resistance training will be performed at Fast Forward Gym, Omaha, NE.
The primary outcome exercise data include strength and endurance Receives: Other: specifically design 6 month resistance training program; Behavioral: 6 months weight resistance and balance program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine activation differences in neural regions serving motor function
Determine activation differences in the neural regions serving motor function using MEG in a group of MS patients, comparing MS affected portions of the brain versus non-affected .Comparison of MEG and DTI measures and whether changes occur after an exercise intervention.
Measured: measure after 6 months training session
Secondary outcomes (1)
Effect of a 6 month resistance and balance program on activation in sensorimotor brain areas
Determine effect of a 6 month resistance and balance program on activation in sensorimotor brain areas using MEG, and correlate changes in these neural indices with those of specific movement and balance.
Measured: following 6 months of exercise sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study start16 Sep 2013
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
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 NebraskaThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Mary L Filipi, PhD, APRN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816100
- Sponsor's protocol ID
- 0039-13-EP
- Acronym
- remapping
- Status last verified
- Aug 2023
- First submitted
- 25 Feb 2013
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients: A Multimodal Neuroimaging Investigation
- ClinicalTrials.gov ID
- NCT01816100
- Acronym / sponsor ID
- remapping / 0039-13-EP
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, exercise, MEG, DTI, Brain changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- 16 Sep 2013 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 21 Mar 2013 (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.
This study is a unique blend of new technologies never used in combination with individuals diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in brain activity, functional brain activation and diffusion in the brain following 6 months of structured weight resistance and balance training. Positive changes would indicate that the therapy has ignited brain plasticity and may drive the brain to repair itself. These changes to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and slowing of neural degeneration. No other trials have been published evaluating brain plasticity utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in subjects with MS undergoing physical training. DTI has demonstrated the ability to find changes (plasticity) that occur in the brain and using the MEG findings to focus the DTI analysis will optimize the capacity to detect changes secondary to therapy. This quantification will give a better understanding of the repair that goes on in the brain, and may potentially revolutionize the field of the central nervous system (CNS) rehabilitation. One of the most innovative aspects of this study is the full integration of clinical neurobehavioral metrics and functional imaging data in conjunction with a proven MS therapy along with quality of life indicators. This approach will allow new links to be illuminated as the trajectories of functional and structural brain changes (neuroplasticity) are meshed with clinical improvement indices collected visit-by-visit. This study will also compare disease modifying treatments (DMTs) and their effect(s) on indices of brain plasticity and cognitive and behavioral assessments.
Detailed description
Rationale MEG is a direct measure of ongoing neurophysiological activity and is appropriate because of spatiotemporal resolution of measurements and immunity of the technique to vascular biases that contaminate functional MRI imaging of MS patients.4 MEG will help to illuminate the brain bases of motor deficits that exist relative to healthy controls and show how the improvements observed behaviorally are reflected in the brain activity that underlies those improvements. Since DTI has demonstrated the ability to find changes (plasticity) that occur in the brain in patients, it is very promising that DTI will be able to detect evidence of neuroplasticity in our research population.5 Using the MEG findings to sharpen the DTI analysis, a very powerful combination, will optimize the ability to detect and understand changes.
Objectives Specific Aim 1 - Determine if there are activation differences (see below) in the neural regions serving motor function during basic movements using MEG in a group of MS patients, comparing MS affected portions of the brain versus non-affected.
Specific Aim 2 - Determine the effect of a specific 6 month resistance and balance exercise program on activation in sensorimotor brain areas using MEG, and correlate changes in these neural indices with those of specific movement and balance.
Specific Aim 3 - Determine the effect of a specific 6 month resistance and balance exercise program on brain diffusivity and fractional anisotropy using DTI and correlate changes in these metrics with improvement in strength and balance measures in subjects with MS, comparing MS affected portions of the brain versus non-affected areas..
Specific Aim 4 - Determine whether increased fiber integrity (fractional anisotropy) along the corticospinal tract is reflected in MEG activation metrics of the primary motor cortex from baseline to 6 months in subjects with MS enrolled in the three-month resistance and balance exercise program.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise session | Experimental | Other: specifically design 6 month resistance training program, Behavioral: 6 months weight resistance and balance program6 months weight resistance session, with before/after evaluations by MEG and DTI. Fifty minute exercise sessions, twice weekly will be done. Each session will rotate between 3 separate exercise protocols: Static weights, free weights and balance. Exercises will be done with each extremity independently. For consistency and convenience, the resistance training will be performed at Fast Forward Gym, Omaha, NE. The primary outcome exercise data include strength and endurance |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of relapsing/remitting or secondary progressive MS by McDonald Criteria (for patient groups)
- Competent to give informed consent.
- ≥ 19 years and <65 years of age.
- EDSS score <7.0 and able to walk 25 feet with or without a cane.
- Willingness to comply with the evaluation schedule for the study. This includes participation in a bi-weekly standardized structured resistance training and separate data collections done at each time point (baseline and 3 months).
Key exclusion criteria (9 listed)
- Unable to give informed consent.
- Unable or unwilling to sign safety waiver.
- EDSS score ≥7 or are unable to walk 25 feet with the use of a cane
- Unwilling or unable to complete the exercise program and other aspects of the study (e.g., not keeping appointments, lack of active participation in the exercise sessions, or displaying inability to follow instructions allowing appropriate exercise advancement).
- Pregnant, breastfeeding or within 3 months post partum at initiation of study.
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 |
|---|---|---|
| specifically design 6 month resistance training programAlso: 6 months weight resistance session,Data will be kept on the number of repetitions and amount of weight per exercise session See intervention description | Other | exercise session |
| 6 months weight resistance and balance programAlso: 50-minute, biweekly sessions for 6 months3 phases first phase-strength improvement using stationary machines second phase-time is divided between stationary machines, balance, dexterity third phase-free weight movements | Behavioural | exercise session |
Primary outcome
Determine activation differences in neural regions serving motor function
Time frame: measure after 6 months training session
Determine activation differences in the neural regions serving motor function using MEG in a group of MS patients, comparing MS affected portions of the brain versus non-affected .Comparison of MEG and DTI measures and whether changes occur after an exercise intervention.
1 secondary outcome
Effect of a 6 month resistance and balance program on activation in sensorimotor brain areas
Time frame: following 6 months of exercise sessions
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 1 Sep 2023.
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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.
Mary L Filipi, PhD, APRN principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specifically design 6 month resistance training program and 6 months weight resistance and balance program in people with Multiple Sclerosis, run by University of Nebraska 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 6 inclusion and 9 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 1 Sep 2023. 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?
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?
Determine activation differences in neural regions serving motor function (time frame: measure after 6 months training session). 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 1 Sep 2023.