An interventional study of Acute Exercise in Epilepsy, Functional Neurological Disorder and Mild Cognitive Impairment, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Basic science
The goal of this study is to investigate how a one-time exercise session influences different parameters of brain function in people with neurological diseases compared to healthy volunteers. The main questions the study aims to answer are:
Participants will take part in a single, one-day study visit and will be asked to:
This study aims to investigate the physiological and neurobiological response to an acute bout of exhaustive exercise in patients with different neurological diseases (epilepsy, functional neurological disorders, mild cognitive impairment, dementia, Parkinson's disease, concussion, and brain tumors). In addition, cardiorespiratory fitness, exercise performance, as well as objective and subjective physical exhaustion will be characterized. Outcomes in participants with neurological diseases will be compared to those of healthy control participants.
All participants will perform a one-time exhaustive cardiopulmonary exercise test (CPET) on a bicycle ergometer. During exercise, continuous electrocardiography (ECG) and respiratory gas measurements (spiroergometry) will be recorded to assess maximal oxygen consumption (VO2max) and other measures of exercise capacity and response. Before and after the exercise test, participants will undergo magnetic resonance imaging (MRI) to assess structural and functional brain measures as well as neurochemical and metabolic markers. Blood-based biomarkers and autonomic nervous system activity will also be assessed before and after exercise.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's planned enrollment of 240 is above the median of 50 across 1,228 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
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Exclusion Criteria:
All participants will undergo one-time exhaustive cardiopulmonary exercise testing (CPET).
Behavioral: Acute Exercise
Cardiopulmonary exercise testing (CPET) will be performed on a bicycle ergometer using a standardized incremental ramp protocol until maximal voluntary exhaustion.
Changes in functional brain network economy measures from pre- to post-exercise
Resting-state functional connectivity and graph theory measures in whole brain, central autonomic network, and default mode network. Assessed before and after an acute bout of exercise using functional magnetic resonance imaging.
Time frame: Before exercise (baseline) and immediately after acute exercise (approximately 10 to 20 minutes) in a single study visit
Changes in brain metabolites from pre- to post-exercise
Neurochemical and metabolic markers across several brain regions, including N-acetyl aspartate (NAA; neuronal marker), myoinositol (mI; glial marker), glutamate (excitatory neurotransmitter), creatine (Cr; energy marker), choline (Cho; membrane turnover), and lactate. Assessed before and after an acute bout of exercise using magnetic resonance spectroscopy.
Time frame: Before exercise (baseline) and immediately after acute exercise (approximately 10 to 20 minutes) in a single study visit
Changes in blood-based biomarkers from pre- to post-exercise
Inflammatory and neurotrophic plasma biomarkers assessed before and after an acute bout of exercise using ultrasensitive targeted immunoassays.
Time frame: Before exercise (baseline) and immediately after acute exercise (approximately 10 to 20 minutes) in a single study visit
Changes in autonomic nervous system activity from pre- to post-exercise
Heart-rate-variability (HRV) and electrodermal activity (EDA) parameters assessed before and after an acute bout of exercise using a wearable wrist sensor.
Time frame: Before exercise (baseline) and immediately after acute exercise (approximately 10 to 20 minutes) in a single study visit
Cardiorespiratory Fitness
Maximal oxygen uptake (relative VO2max) assessed during acute exercise (cardiopulmonary exercise testing).
Time frame: One-time measurement during acute exercise (approximately 10 to 20 minutes).
Exercise Performance
Maximal workload (Watt per kilogram body weight) achieved during acute exercise (cardiopulmonary exercise testing).
Time frame: One-time measurement during acute exercise (approximately 10 to 20 minutes).
Objective exhaustion
Achievement of predefined objective exhaustion criteria assessed by spirometry and heart rate data during acute exercise (cardiopulmonary exercise testing).
Time frame: One-time measurement during acute exercise (approximately 10 to 20 minutes).
Subjective exhaustion
Maximal subjective rating of perceived exertion (RPE) assessed using the Borg scale during acute exercise (cardiopulmonary exercise testing). The Borg scale measures the subjective level of exertion on a scale from 6 (no exertion) to 20 (maximal exertion).
Time frame: One-time measurement during acute exercise (approximately 10 to 20 minutes).
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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