Concussion, MildTECHSNCT06494592
The Exercise and Concussion Health Study
A study testing Aerobic Exercise and Balance Exercise in people with Concussion, Mild and Concussion, Brain, run by Northeastern University at 1 site in United States.
Trial summary
This study aims to investigate the effect of two different physical exercise interventions on the brain, cognition and patient reported outcomes following a mild traumatic brain injury (mTBI) in community-dwelling adults. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Concussion, Mild, Concussion, Brain, TBI (Traumatic Brain Injury)
- What is being tested?
- Aerobic Exercise and Balance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Suffered from a clinically diagnosed mild traumatic brain injury (concussion) within 1 year of injury.
- All potential participants who do not have an official concussion diagnosis from a physician or were not recruited directly from Concussion and Brain Injury clinic at Beth Israel Deaconess Medical Center (BIDMC) will have a phone-based consultation with a trained neurologist from BIDMC to confirm a diagnosis of mTBI, (i.e. any loss of consciousness of up to 30 mins, any loss of memory for events immediately before or after the accident for as much as 24h, any alteration in mental state at the time of the accident and a Glasgow coma score of 13 to 15) (Marshall et al., 2012) per a reliance agreement between Beth Israel Deaconess medical center and northeastern university.
- Men and women of all ethnicities/races and socio-economic status.
- 18-55 years.
- Signed Informed consent.
- Physically fit enough to undergo exercise as screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the cardiovascular section of the Health History \& Demographics Questionnaire. An affirmative response (i.e., "yes") to any single item regarding an individual's health status is grounds for the necessary medical clearance before enrollment.
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- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision).
- Able to speak, read, and write English.
- Ambulatory without pain or the assistance of walking devices.
- Reliable means of transportation.
- No diagnosis of a neurological disease.
- MRI compatible.
- No brain bleeds.
Who cannot join
- Diagnosis of a moderate-to-severe TBI (Glasgow Coma Score of 3-12) or the presentation of skull breach and/or presence of known subdural hematoma.
- Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
- Not fluent in English.
- Not medically cleared for exercise.
- Not MRI compatible.
- No history of vasovagal episodes. (sudden drops in heart rate, poor perfusion, constant dizziness)
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- History of brain bleeds or strokes.
- Neurological condition (MS, Parkinson's, Dementia, MCI).
- Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep-vein thrombosis or other cardiovascular events.
- Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac conditions in the past year.
- Regular use of an assisted walking device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02120
About this study
Official title: The Exercise and Concussion Health Study (TECHS)
This study aims to investigate the effect of two different physical exercise interventions on the brain, cognition and patient reported outcomes following a mild traumatic brain injury (mTBI) in community-dwelling adults.
Physical exercise as an intervention for mTBI has great potential yet there is limited high-quality evidence of its effect. Additionally, while standardized exercise protocols for sport-related concussion exist, a similar program is not available to members of the general public who have suffered a mTBI. This study therefore aims to test the effect of a 3-month exercise protocol either focusing on balance or aerobic exercises. The results from the study may lead to advances in evidenced-based mTBI management and provide clinicians with an effective intervention that can improve brain and cognitive recovery after mTBI.
Read the detailed description
This is a 12-week two arm pilot randomized control trial comparing two types of exercise interventions. Both groups will complete three 30-minute remote exercise sessions weekly, via Zoom delivered by a trained interventionist and supervised by a dedicated safety officer. Participants will be randomly assigned to either aerobic or balance based exercise for the duration of the study. Participants will sign informed consent in person during a baseline visit where measures of brain (magnetic resonance imaging [MRI] and electroencephalography [EEG]), cognition, patient reported outcomes and lifestyle questionnaires are collected. Participants will repeat this session in-person at the end of the 12-week intervention. Participants will wear a wrist-worn Actigraph for 7 consecutive days at 3 time points throughout the intervention period (once each month) to collect daily physical activity levels and sleep metrics. Both interventions will be individualized and progressive in terms of intensity and difficulty. The exercise interventions sessions will be thresholded at a heart rate of 80% symptom threshold assessed at baseline using a modified cycle and fitness test.
- Conditions
- Concussion, Mild, Concussion, Brain, TBI (Traumatic Brain Injury), TBI
- Being tested
- Aerobic Exercise, Balance Exercise
- Keywords
- Brain, TBI, Concussion
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Participants in the aerobic exercise intervention group will engage in a virtual aerobic exercise intervention three times a week for 12 weeks for a 30-minute session (5 minute warm up, 20 minutes of aerobic exercise, 5 minutes cooldown) and will receive information about the session prior to their appointment. Sessions have a goal of reaching at least 20 minutes of supervised exercise performed at 80% of the heart rate at symptom threshold.
Balance ExerciseBehavioural
Participants in the balance exercise intervention group will participate in a staff-led virtual session three times a week for 12 weeks for a 30-minute session and will receive information about the session prior to their appointment. This group will focus on improving balance, with some additional work on flexibility and strength.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | Not described Receives: Behavioral: Aerobic Exercise |
| Balance Exercise Group | Active comparator | Not described Receives: Behavioral: Balance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail Making Test
Cognitive task evaluating executive functioning and processing speed is administered at Baseline and Endpoint at 12 weeks.
Measured: 12 Weeks
Hopkins Verbal Learning Test
Cognitive task evaluating immediate and delayed memory is administered at Baseline and Endpoint at 12 weeks.
Measured: 12 Weeks
Letter and Category Fluency Test
Cognitive task evaluating verbal fluency is administered at Baseline and Endpoint at 12 weeks.
Measured: 12 Weeks
Secondary outcomes (11)
White Matter Diffusion Properties
Completed and analyzed after Baseline and Endpoint via MRI. Diffusion weighted imaging used to measure changes in white matter microstructure.
Measured: 12 Weeks
Resting State Functional Connectivity
Completed and analyzed after Baseline and Endpoint via MRI. Functional MRI scan used to measure changes in resting state brain function via resting state connectivity metrics.
Measured: 12 Weeks
Brain Morphology
Completed and analyzed after Baseline and Endpoint via MRI. Anatomical T1w MRI scan used to measure volume and determine changes in volume over the course of the intervention.
Measured: 12 Weeks
Cerebral Blood Flow
Completed and analyzed after Baseline and Endpoint via MRI. Arterial spin labeling used to measure changes in cerebral blood flow with total cerebral blood flow change.
Measured: 12 Weeks
Electroencephalography (EEG) Power Metrics
From eyes-open and eyes-closed scans: EEG power metrics within the canonical frequency bands (delta, theta, alpha, beta1, beta2, gamma).
Measured: 12 Weeks
EEG Scan- Aperiodic Metrics
From eyes-open and eyes-closed scans: Aperiodic metrics derived from the Fitting Oscillations one over F (FOOOF) algorithm being the aperiodic offset and exponent along with peak power and bandwidth.
Measured: 12 Weeks
Daily Physical Activity Levels- Accelerometers
Wrist-worn Actigraph device is utilized to collect physical activity and sleep metrics at three time points for 7 consecutive days during the 12-week participation.
Measured: 12 Weeks
PROMIS- Patient-Reported Outcomes Measurement Information Systems
Questionnaire collected at Baseline and Endpoint: Self-reported global and cognitive health.
Measured: 12 Weeks
Pittsburgh Sleep Quality Index
Questionnaire collected at Baseline and Endpoint. Self-Reported Questionnaire about sleep duration and quality.
Measured: 12 Weeks
International Physical Activity Questionnaire.
Questionnaire collected at Baseline and Endpoint. Self-reported physical activity measurement.
Measured: 12 Weeks
Symptomology
California Interscholastic Federation Graded Concussion Symptom checklist, collected during the baseline session, throughout each intervention session and again at post-test session to assess concussion-related symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Feb 2023
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Morris, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494592
- Sponsor's protocol ID
- 22-10-15
- Acronym
- TECHS
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exercise and Concussion Health Study (TECHS)
- ClinicalTrials.gov ID
- NCT06494592
- Acronym / sponsor ID
- TECHS / 22-10-15
- Conditions
- Concussion, Mild, Concussion, Brain, TBI (Traumatic Brain Injury), TBI
- Keywords
- Brain, TBI, Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of two different physical exercise interventions on the brain, cognition and patient reported outcomes following a mild traumatic brain injury (mTBI) in community-dwelling adults.
Physical exercise as an intervention for mTBI has great potential yet there is limited high-quality evidence of its effect. Additionally, while standardized exercise protocols for sport-related concussion exist, a similar program is not available to members of the general public who have suffered a mTBI. This study therefore aims to test the effect of a 3-month exercise protocol either focusing on balance or aerobic exercises. The results from the study may lead to advances in evidenced-based mTBI management and provide clinicians with an effective intervention that can improve brain and cognitive recovery after mTBI.
Detailed description
This is a 12-week two arm pilot randomized control trial comparing two types of exercise interventions. Both groups will complete three 30-minute remote exercise sessions weekly, via Zoom delivered by a trained interventionist and supervised by a dedicated safety officer. Participants will be randomly assigned to either aerobic or balance based exercise for the duration of the study. Participants will sign informed consent in person during a baseline visit where measures of brain (magnetic resonance imaging [MRI] and electroencephalography [EEG]), cognition, patient reported outcomes and lifestyle questionnaires are collected. Participants will repeat this session in-person at the end of the 12-week intervention. Participants will wear a wrist-worn Actigraph for 7 consecutive days at 3 time points throughout the intervention period (once each month) to collect daily physical activity levels and sleep metrics. Both interventions will be individualized and progressive in terms of intensity and difficulty. The exercise interventions sessions will be thresholded at a heart rate of 80% symptom threshold assessed at baseline using a modified cycle and fitness test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Behavioral: Aerobic Exercise |
| Balance Exercise Group | Active comparator | Behavioral: Balance Exercise |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Suffered from a clinically diagnosed mild traumatic brain injury (concussion) within 1 year of injury.
- All potential participants who do not have an official concussion diagnosis from a physician or were not recruited directly from Concussion and Brain Injury clinic at Beth Israel Deaconess Medical Center (BIDMC) will have a phone-based consultation with a trained neurologist from BIDMC to confirm a diagnosis of mTBI, (i.e. any loss of consciousness of up to 30 mins, any loss of memory for events immediately before or after the accident for as much as 24h, any alteration in mental state at the time of the accident and a Glasgow coma score of 13 to 15) (Marshall et al., 2012) per a reliance agreement between Beth Israel Deaconess medical center and northeastern university.
- Men and women of all ethnicities/races and socio-economic status.
- 18-55 years.
- Signed Informed consent.
Key exclusion criteria (11 listed)
- Diagnosis of a moderate-to-severe TBI (Glasgow Coma Score of 3-12) or the presentation of skull breach and/or presence of known subdural hematoma.
- Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
- Not fluent in English.
- Not medically cleared for exercise.
- Not MRI compatible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseParticipants in the aerobic exercise intervention group will engage in a virtual aerobic exercise intervention three times a week for 12 weeks for a 30-minute session (5 minute warm up, 20 minutes of aerobic exercise, 5 minutes cooldown) and will receive information about the session prior to their appointment. Sessions have a goal of reaching at least 20 minutes of supervised exercise performed at 80% of the heart rate at symptom threshold. | Behavioural | Aerobic Exercise Group |
| Balance ExerciseParticipants in the balance exercise intervention group will participate in a staff-led virtual session three times a week for 12 weeks for a 30-minute session and will receive information about the session prior to their appointment. This group will focus on improving balance, with some additional work on flexibility and strength. | Behavioural | Balance Exercise Group |
Primary outcome
Trail Making Test
Time frame: 12 Weeks
Cognitive task evaluating executive functioning and processing speed is administered at Baseline and Endpoint at 12 weeks.
Hopkins Verbal Learning Test
Time frame: 12 Weeks
Cognitive task evaluating immediate and delayed memory is administered at Baseline and Endpoint at 12 weeks.
Letter and Category Fluency Test
Time frame: 12 Weeks
Cognitive task evaluating verbal fluency is administered at Baseline and Endpoint at 12 weeks.
11 secondary outcomes
White Matter Diffusion Properties
Time frame: 12 Weeks
Resting State Functional Connectivity
Time frame: 12 Weeks
Brain Morphology
Time frame: 12 Weeks
Cerebral Blood Flow
Time frame: 12 Weeks
Electroencephalography (EEG) Power Metrics
Time frame: 12 Weeks
EEG Scan- Aperiodic Metrics
Time frame: 12 Weeks
Daily Physical Activity Levels- Accelerometers
Time frame: 12 Weeks
PROMIS- Patient-Reported Outcomes Measurement Information Systems
Time frame: 12 Weeks
Pittsburgh Sleep Quality Index
Time frame: 12 Weeks
International Physical Activity Questionnaire.
Time frame: 12 Weeks
Symptomology
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Balance Exercise in people with Concussion, Mild and Concussion, Brain, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making Test (time frame: 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.