EpilepsyEXPLAINNCT07883720
EXercise-induced PhysioLogical Adaptations In Neurological Disorders
A study testing Acute Exercise in people with Epilepsy and Functional Neurological Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Functional Neurological Disorder, Mild Cognitive Impairment
- What is being tested?
- Acute Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2026to Dec 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Clinical diagnosis of one of the following neurological diseases: epilepsy, functional neurological disorder, mild cognitive impairment, dementia, Parkinson's disease, concussion, brain tumor [for participants with neurological diseases]
- No diagnosis of neurological disease [for healthy control participants]
Who cannot join
- Non-english speaking individuals
- Exercise contraindications (e.g., physical impairments limiting use of bicycle ergometer, acute infections, severe heart disease, uncontrolled hypertension, exercise associated seizures)
- Current use of medications for cardiac rhythm or rate control
- Magnetic resonance imaging (MRI) contraindications (e.g., electrical implants, ferromagnetic implants or objects, pregnancy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Claus Reinsberger, MD, PhD, 617-804-5828, creinsberger@mgb.org
About this study
Official title: Exercise Testing for Neurological Conditions
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:
- How do fitness level, exercise performance, and physical exhaustion differ between patients with neurological diseases and healthy participants?
- How does acute exercise affect brain function and other physiological biomarkers in participants with neurological diseases?
Read more
Participants will take part in a single, one-day study visit and will be asked to:
- Perform a standardized exercise test on a bicycle ergometer
- Undergo a brain MRI (magnetic resonance imaging) scan, a blood draw, and autonomic measurements before and after the exercise test
Read the detailed description
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.
- Conditions
- Epilepsy, Functional Neurological Disorder, Mild Cognitive Impairment, Dementia, Parkinson Disease, Concussion, Brain
- Being tested
- Acute Exercise
- Keywords
- Exercise, Cardiorespiratory Fitness, Neuroimaging, Autonomic Nervous System
- Medical subject headings
- Epilepsy, Conversion Disorder, Cognitive Dysfunction, Dementia, Parkinson Disease, Brain Concussion, Brain Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute ExerciseBehavioural
Cardiopulmonary exercise testing (CPET) will be performed on a bicycle ergometer using a standardized incremental ramp protocol until maximal voluntary exhaustion.
| Study group | Role | What they receive |
|---|---|---|
| Acute Exercise | Experimental | All participants will undergo one-time exhaustive cardiopulmonary exercise testing (CPET). Receives: Behavioral: Acute Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before exercise (baseline) and immediately after acute exercise (approximately 10 to 20 minutes) in a single study visit
Secondary outcomes (4)
Cardiorespiratory Fitness
Maximal oxygen uptake (relative VO2max) assessed during acute exercise (cardiopulmonary exercise testing).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: One-time measurement during acute exercise (approximately 10 to 20 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start22 Jul 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants perform a cardiopulmonary exercise test on a bicycle ergometer and undergo a standardized testing protocol pre- and post-exercise. Participants are characterized by pre-existing neurological disease status or healthy control status. Physiological and neurobiological responses to exercise are assessed before and after exercise and compared across the predefined participant groups.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Reinsberger, Brigham and Women's Hospital
- Investigators
- Claus Reinsberger, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883720
- Sponsor's protocol ID
- 2025P003143
- Acronym
- EXPLAIN
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No