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Behavioural Intervention
AIH + NMES for Multiple Sclerosis
N/A
Waitlist Available
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of relapsing form of MS
Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
Must not have
Uncontrolled medical problems affecting the lungs (pulmonary diseases including chronic obstructive pulmonary disease), the heart (cardiovascular diseases) or the musculoskeletal system (orthopedic diseases)
Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately prior to and within 60 minutes after the intervention.
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if using neuromuscular electrical stimulation can improve nerve activity in people with relapsing form multiple sclerosis. The study will compare the effects of combining AIH with NMES
Who is the study for?
This trial is for individuals with relapsing multiple sclerosis. Participants should be able to perform the required physical tasks and have no other health conditions that could interfere with the study.
What is being tested?
The study is testing how well neuromuscular electrical stimulation (NMES) works when combined with acute intermittent hypoxia (AIH). It's looking at muscle strength and nerve responses in people with MS, comparing NMES alone, AIH alone, and both together.
What are the potential side effects?
Possible side effects may include discomfort from electrical stimulation or breathing issues due to hypoxia. The exact side effects will depend on individual tolerance to these interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is a relapsing form of multiple sclerosis.
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My disability level is moderate to severe but I can still walk.
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I have been free from cancer relapse for at least 1 year.
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My ability to move around is moderately affected.
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I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled lung, heart, or musculoskeletal problems.
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I am taking medication that affects my brain and could make seizures more likely.
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I have a neurological condition not related to MS.
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I often have severe or unexplained headaches.
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My blood pressure is within the normal range.
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I have a history of epilepsy or seizures.
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I do not have ongoing major depression, psychosis, or cognitive issues.
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I have had a stroke in the past.
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I have had surgery on my head.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately prior to and within 60 minutes after the intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately prior to and within 60 minutes after the intervention.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Motor Evoked Potentials (MEPs) in Ankle Dorsiflexors
Secondary study objectives
Ankle Dorsiflexion EMG
Ankle Dorsiflexion Torque
Symbol Digit Modalities Test
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: NMES aloneExperimental Treatment1 Intervention
Participants will undergo repetitive common peroneal nerve stimulation for up to 30 minutes.
Group II: Combined AIH and NMESExperimental Treatment2 Interventions
Participants will undergo 30 minutes of AIH. Immediately following, participants will undergo NMES for up to 30 minutes.
Group III: AIH aloneExperimental Treatment1 Intervention
Participants will undergo 30 minutes of AIH.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
18,005 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
405 Patients Enrolled for Multiple Sclerosis
Northwestern UniversityOTHER
1,645 Previous Clinical Trials
958,574 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
415 Patients Enrolled for Multiple Sclerosis
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