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Exercise for Memory Improvement in Epilepsy
N/A
Recruiting
Led By Jane B. Allendorfer, Ph.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinician-confirmed diagnosis of IGE (including epilepsy syndromes such as juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, and generalized tonic-clonic seizures alone)
Males and females aged 18-55 years old
Must not have
Abnormal general or neurological examination
High blood pressure that is not controlled by medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-weeks after baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if an exercise program can improve memory in adults with epilepsy by making their brain work better, especially the part that helps with remembering things.
Who is the study for?
This trial is for English-speaking adults aged 18-55 with Idiopathic generalized epilepsy (IGE) who are relatively healthy, not very active physically, and have had no more than 4 seizure days per month in the past half year. They must be able to undergo MRI scans and cannot be pregnant or involved in another intervention study.
What is being tested?
The study tests a 6-week supervised exercise program's effectiveness on memory improvement in IGE patients compared to those with no intervention. It also examines brain changes due to the exercise and if improvements persist after six weeks post-intervention.
What are the potential side effects?
While specific side effects aren't listed for this type of physical training, participants may experience typical exercise-related discomforts such as muscle soreness, fatigue, or strain injuries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of generalized epilepsy.
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I am between 18 and 55 years old.
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I've had 4 or fewer days with seizures each month for the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had an abnormal physical or neurological exam.
Select...
My high blood pressure is not managed with medication.
Select...
I have a history of heart or blood vessel problems.
Select...
I've had more than 4 seizure days each month for the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-weeks after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-weeks after baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
estimated interaction effect between exercise group and visit for d'
estimated mediation effect of change in left hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'
Secondary study objectives
estimated interaction effect between exercise group and visit for Learning score
estimated interaction effect between exercise group and visit for Long Delay Free Recall score
estimated interaction effect between exercise group and visit for Montreal Cognitive Assessment (MoCA) score
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Immediate ExerciseExperimental Treatment1 Intervention
immediate participation in 6-week exercise program (intervention)
Group II: Delayed ExerciseExperimental Treatment1 Intervention
6-week delay (no-intervention control) prior to participating in exercise program
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,259 Total Patients Enrolled
Jane B. Allendorfer, Ph.D.Principal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects my body's normal processes.Your brain MRI shows abnormal results.You meet the physical activity recommendations from the American Heart Association for adults.I have been diagnosed with a type of generalized epilepsy.You have a history of learning difficulties or have a low score on an intelligence test.I am between 18 and 55 years old.I have had an abnormal physical or neurological exam.My high blood pressure is not managed with medication.You don't exercise enough according to the American Heart Association's guidelines for adults.I have a history of heart or blood vessel problems.You should not have an MRI scan at 3-Tesla.I've had 4 or fewer days with seizures each month for the last 6 months.You should not have any health conditions that would make it unsafe for you to have a 3-Tesla MRI scan.You have had thoughts of hurting yourself in the past 3 months.I've had more than 4 seizure days each month for the last 6 months.My recent brain MRI, if available, shows no abnormalities.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Exercise
- Group 2: Delayed Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.