Clinical trial NCT04959019: Exercise for Memory Rehabilitation in Epilepsy
Official title: Exercise for Memory Rehabilitation in Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy, Generalized
Memory Impairment
Keywords: Epilepsy, Idiopathic Generalized
Memory Impairment
Magnetic Resonance Imaging
Neuroimaging
Endurance and Resistance Training
Resting State Functional Connectivity
Verbal Learning and Memory
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study utilizes a randomized delayed intervention study design. Participants are randomized to a 6-week exercise program (intervention), or to a 6-week delay (no-intervention control) prior to beginning the exercise program.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how effective a 6-week exercise program is for improving memory compared to a no-intervention control group, investigate the brain changes that may be responsible for memory improvements, and determine if the memory benefits and brain changes are retained 6 weeks after completing the exercise intervention in people with Idiopathic generalized epilepsy (IGE).

Detailed description: The primary objectives of this randomized controlled trial are to determine in adults with idiopathic generalized epilepsy (IGE) the efficacy of a 6-week supervised and structured exercise program combining endurance and resistance training for memory rehabilitation, investigate a putative mechanisms of action for exercise-related memory benefits, and determine if the memory benefits and brain changes are retained 6 weeks after completing the exercise intervention. Based on the investigators' pilot exercise data in adults with epilepsy, they hypothesize that exercise will significantly improve verbal memory function in the exercise group compared to the no-intervention control group. The investigators also hypothesize that the verbal memory improvements are mediated by the changes in resting state functional connectivity (rsFC) of the hippocampus, a brain region that plays a vital role in memory function. The investigators propose a mediation model in which exercise-induced changes in the hippocampus rsFC is mediating the beneficial effect of exercise on memory function in epilepsy, and will utilize the causal-steps approach in which 4 conditions of statistical significance must be met to determine if mediation is present.

Eligibility criteria: Inclusion Criteria:

* males and females
* ages 18-65 years old
* speaks English fluently
* able to provide written informed consent
* have no contraindications to 3-Telsa MRI
* clinician-confirmed diagnosis of IGE (IGE includes epilepsy syndromes such as juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, and generalized tonic-clonic seizures alone)
* relatively healthy with no comorbid medical conditions besides epilepsy
* normal pre-enrollment structural clinical MRI of the brain (if available)
* having less than the American Heart Association recommendation of physical activity in adults (at least 30 min moderate-intensity aerobic activity at least 5 days/week (150 min total), or at least 25 min vigorous aerobic activity at least 3 days/week (75 min total) and moderate-/high-intensity muscle strengthening activity at least 2 days/week)

Exclusion Criteria:

* underlying degenerative or metabolic disorders
* abnormal general or neurological examination
* abnormal brain MRI
* recent suicidal ideation in the last 3 months determined based on previous medical history
* pregnant or positive pregnancy test result on the day of the research session
* contraindication to an MRI scan at 3-Telsa
* mental handicap (FSIQ\<80 if tested) or history of special education
* concurrent participation in a different intervention study
* diseased or enlarged heart or blood vessels determined based on previous medical history
* high blood pressure that is not controlled by medications
* meeting the American Heart Association recommendation of physical activity in adults
* abnormal physical examination in which study physician determines subject should not participate in the exercise intervention

Primary outcomes:
measure: estimated interaction effect between exercise group and visit for d'
timeFrame: 6 weeks after baseline
measure: estimated mediation effect of change in left hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'
timeFrame: 6 weeks after baseline
Secondary outcomes:
measure: estimated interaction effect between exercise group and visit for Learning score
timeFrame: 6-weeks after baseline
measure: estimated interaction effect between exercise group and visit for Long Delay Free Recall score
timeFrame: 6-weeks after baseline
measure: estimated mediation effect of change in right hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'
timeFrame: 6-weeks after baseline
measure: estimated interaction effect between exercise group and visit for Montreal Cognitive Assessment (MoCA) score
timeFrame: 6-weeks after baseline
measure: estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) physical component score
timeFrame: 6-weeks after baseline
measure: estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) mental component score
timeFrame: 6-weeks after baseline
measure: estimated interaction effect between exercise group and visit for Long Delay Cued Recall score
timeFrame: 6 weeks after baseline
measure: estimated interaction effect between exercise group and visit for Short Delay Cued Recall score
timeFrame: 6 weeks after baseline
measure: estimated mediation effect of change in right hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in Long Delay Cued Recall score
timeFrame: 6-weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jane B. Allendorfer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: