Traumatic Brain InjuryNCT06222502
Walking After Traumatic Brain Injury in Older Adults
A study testing Planning, Reminders, and Micro-Incentives and Health Education in people with Traumatic Brain Injury and TBI, run by Timothy Morris at 1 site in United States.
Trial summary
The purpose of this research is to learn if different behavioral interventions can change walking behaviors over 12-weeks, in older adults who have previously suffered a non-penetrating mild or moderate TBI. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Traumatic Brain Injury, TBI, Mild Traumatic Brain Injury
- What is being tested?
- Planning, Reminders, and Micro-Incentives and Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 12 Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffered a mild or moderate traumatic brain injury within 3 months to 15 years prior to recruitment.
- TBI history will be assessed using the validated OSU TBI history questionnaire (Attachment 1). TBI severity will be defined as loss of consciousness of 0-30 minutes (mild) or \>30 minutes and \<24 hours (moderate). If no loss of consciousness was reported but post-traumatic amnesia was reported, then this is considered a mild TBI.
- If clinical reports from the time of injury are available and Glasgow Coma Scale scores are available, then 13-15 is considered mild and 9-12 moderate. A clinical neurologist will review the de-identified OSU TBI forms for accuracy and confirm TBI severity.
- Men and women of all ethnicities/races and socio-economic status.
- 40-80 years.
- Signed Informed consent.
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- 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.
- 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 (if participating in Boston).
- No diagnosis of a neurological disease.
- No intracerebral brain bleeds.
- Access to a mobile device, laptop or desktop computer with internet access and Bluetooth.
Who cannot join
- Diagnosis of a severe TBI (loss of consciousness \>24 hours, post-traumatic amnesia \> 7 days of a Glasgow Coma Scale of \<9) or the presentation of skull breach.
- Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
- Not fluent in English.
- Undergoing any speech or physical therapy
- Not medically cleared for exercise.
- No history of vasovagal episodes (sudden drops in heart rate, poor perfusion, constant dizziness)
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- History of intracerebral brain bleeds or strokes.
- Neurological condition (MS, Parkinson's, Dementia, MCI).
- Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular events.
- Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition 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, 02115
About this study
Official title: Planning, Reminders and Micro-incentives to Increase Walking After Traumatic Brain Injury in Older Adults
The purpose of this research is to learn if different behavioral interventions can change walking behaviors over 12-weeks, in older adults who have previously suffered a non-penetrating mild or moderate TBI.
Participants will provide information and be screened for eligibility via phone screening call (verification of age, confirmation that the participant is not currently on any medication that affects the central nervous system, and verification that the subject can participate in exercise, brief TBI history). Baseline testing will take place at the Center for Cognitive and Brain Health and Northeastern University Biomedical Imaging Center, for the baseline magnetic resonance imaging, in the interdisciplinary science and engineering complex on Northeastern University's campus. In person testing will take place over one session. The study period lasts 12 weeks, during which all participants will 1. Receive a weekly phone call with study staff and 2. Wear a wrist-worn Fit Bit tracker. A remote participation option is available for those who cannot travel to Northeastern University.
Read the detailed description
Older adults are more affected by cognitive impairments due to TBI as compared to younger adults. In addition, older adults are at a much higher risk for sedentary behavior. To address this, we intend to test the effect of two behavioral interventions on walking participation of older adults with a history of mild or moderate TBI. Participants will be randomized to either the planning, reminders, and micro-incentives group or to the health education tips group which are delivered over the phone and available virtually. We will give each participant a Fit Bit for the duration of the study, and we will use it to track their walking. Our primary aim is to see if there is a difference in the activity levels between the groups. Our secondary aim is to see if the MRI data we collect shows intra-brain connections correlate with physical activity.
Our study is a 12-week two arm pilot randomized control trial-comparing two behavioral interventions. In one group, participants will have a weekly phone call with lab staff planning 5 days during each week that they plan on having a 30-minute walk. On the days of the walk, participants will receive either a text or an email, of their choice, reminding them of the planned walk. Participants will earn points for each planned walk completed; these can then be redeemed for a monetary reward at the end of the study. The other group will have a weekly phone call with lab staff where a health education tip is shared. Participants will also be provided a study FitBit where they will wear it during the times of the day when they are active.
Following recruitment and informed consent, each participant will come into ISEC for their baseline assessment. During this assessment they will fill out questionnaires on their health history to include: Physical Activity Readiness Questionnaire, Ohio state university TBI Questionnaire, PROMIS global health and NeuroQoL Questionnaires, Mediterranean diet adherence, International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index, GAD-7, PHQ-9, BREQ-3 Physical Exercise Motivation, and the Physical Exercise Self Efficacy Questionnaire. Next, the participant will be asked to complete a battery of cognitive tests including: Digital and Paper Trail Making, Hopkins Verbal Learning Test, Letter and Category Fluency Test, and a mini mental status exam. This data will all be recorded via redcap. Next, the participant will undergo an MRI. This will take about an hour and the data will be uploaded to the Northeastern Cluster. Upon completion of the baseline session, each participant will be given a Fit Bit and assigned to the health education group or the planning, reminders, and micro-incentives group. Over the next 12 weeks, study staff will have access to the FitBit data collected and complete weekly calls with the participants, the content varying based on which group the participant is in. The final steps for the participants is their remote post testing where they will complete the same cognitive tasks and questionnaires as in their baseline assessment.
- Being tested
- Planning, Reminders, and Micro-Incentives, Health Education
- Keywords
- Brain Injury, TBI, Walking, Exercise
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Brain Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning, Reminders, and Micro-IncentivesOther
Participants will schedule planned walks during weekly phone calls with study staff. Participants will receive reminders for planned walks and receive micro-incentives after completion.
Health EducationOther
Participants in this group will receive health education "tips" during weekly phone calls with study staff.
| Study group | Role | What they receive |
|---|---|---|
| Planning, Reminders, and Micro-Incentives | Experimental | Not described Receives: Other: Planning, Reminders, and Micro-Incentives |
| Health Education | Active comparator | Not described Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of planned walks completed
Measured: 12 Weeks
Secondary outcomes (2)
Functional connectivity of the anterior mid cingulate cortex, the dorsolateral and medial prefrontal cortex and diffusion metrics of the corpus callosum and association fiber tracts of the temporal and frontal lobes
Measured: 12 Weeks
Number of minutes walking per week and total number of steps per week
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 posted24 Jan 2024
- Study start10 Apr 2024
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Morris
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brandeis University
- Responsible party
- Sponsor-investigator, Timothy Morris, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222502
- Sponsor's protocol ID
- 18-06-23
- Other IDs
- P30AG048785
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Planning, Reminders and Micro-incentives to Increase Walking After Traumatic Brain Injury in Older Adults
- ClinicalTrials.gov ID
- NCT06222502
- Acronym / sponsor ID
- 18-06-23
- Keywords
- Brain Injury, TBI, Walking, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Timothy MorrisUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brandeis University
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 24 Jan 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.
The purpose of this research is to learn if different behavioral interventions can change walking behaviors over 12-weeks, in older adults who have previously suffered a non-penetrating mild or moderate TBI.
Participants will provide information and be screened for eligibility via phone screening call (verification of age, confirmation that the participant is not currently on any medication that affects the central nervous system, and verification that the subject can participate in exercise, brief TBI history). Baseline testing will take place at the Center for Cognitive and Brain Health and Northeastern University Biomedical Imaging Center, for the baseline magnetic resonance imaging, in the interdisciplinary science and engineering complex on Northeastern University's campus. In person testing will take place over one session. The study period lasts 12 weeks, during which all participants will 1. Receive a weekly phone call with study staff and 2. Wear a wrist-worn Fit Bit tracker. A remote participation option is available for those who cannot travel to Northeastern University.
Detailed description
Older adults are more affected by cognitive impairments due to TBI as compared to younger adults. In addition, older adults are at a much higher risk for sedentary behavior. To address this, we intend to test the effect of two behavioral interventions on walking participation of older adults with a history of mild or moderate TBI. Participants will be randomized to either the planning, reminders, and micro-incentives group or to the health education tips group which are delivered over the phone and available virtually. We will give each participant a Fit Bit for the duration of the study, and we will use it to track their walking. Our primary aim is to see if there is a difference in the activity levels between the groups. Our secondary aim is to see if the MRI data we collect shows intra-brain connections correlate with physical activity.
Our study is a 12-week two arm pilot randomized control trial-comparing two behavioral interventions. In one group, participants will have a weekly phone call with lab staff planning 5 days during each week that they plan on having a 30-minute walk. On the days of the walk, participants will receive either a text or an email, of their choice, reminding them of the planned walk. Participants will earn points for each planned walk completed; these can then be redeemed for a monetary reward at the end of the study. The other group will have a weekly phone call with lab staff where a health education tip is shared. Participants will also be provided a study FitBit where they will wear it during the times of the day when they are active.
Following recruitment and informed consent, each participant will come into ISEC for their baseline assessment. During this assessment they will fill out questionnaires on their health history to include: Physical Activity Readiness Questionnaire, Ohio state university TBI Questionnaire, PROMIS global health and NeuroQoL Questionnaires, Mediterranean diet adherence, International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index, GAD-7, PHQ-9, BREQ-3 Physical Exercise Motivation, and the Physical Exercise Self Efficacy Questionnaire. Next, the participant will be asked to complete a battery of cognitive tests including: Digital and Paper Trail Making, Hopkins Verbal Learning Test, Letter and Category Fluency Test, and a mini mental status exam. This data will all be recorded via redcap. Next, the participant will undergo an MRI. This will take about an hour and the data will be uploaded to the Northeastern Cluster. Upon completion of the baseline session, each participant will be given a Fit Bit and assigned to the health education group or the planning, reminders, and micro-incentives group. Over the next 12 weeks, study staff will have access to the FitBit data collected and complete weekly calls with the participants, the content varying based on which group the participant is in. The final steps for the participants is their remote post testing where they will complete the same cognitive tasks and questionnaires as in their baseline assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planning, Reminders, and Micro-Incentives | Experimental | Other: Planning, Reminders, and Micro-Incentives |
| Health Education | Active comparator | Other: Health Education |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Suffered a mild or moderate traumatic brain injury within 3 months to 15 years prior to recruitment.
- TBI history will be assessed using the validated OSU TBI history questionnaire (Attachment 1). TBI severity will be defined as loss of consciousness of 0-30 minutes (mild) or \>30 minutes and \<24 hours (moderate). If no loss of consciousness was reported but post-traumatic amnesia was reported, then this is considered a mild TBI.
- If clinical reports from the time of injury are available and Glasgow Coma Scale scores are available, then 13-15 is considered mild and 9-12 moderate. A clinical neurologist will review the de-identified OSU TBI forms for accuracy and confirm TBI severity.
- Men and women of all ethnicities/races and socio-economic status.
- 40-80 years.
Key exclusion criteria (11 listed)
- Diagnosis of a severe TBI (loss of consciousness \>24 hours, post-traumatic amnesia \> 7 days of a Glasgow Coma Scale of \<9) or the presentation of skull breach.
- Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
- Not fluent in English.
- Undergoing any speech or physical therapy
- Not medically cleared for exercise.
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 |
|---|---|---|
| Planning, Reminders, and Micro-IncentivesParticipants will schedule planned walks during weekly phone calls with study staff. Participants will receive reminders for planned walks and receive micro-incentives after completion. | Other | Planning, Reminders, and Micro-Incentives |
| Health EducationParticipants in this group will receive health education "tips" during weekly phone calls with study staff. | Other | Health Education |
Primary outcome
Number of planned walks completed
Time frame: 12 Weeks
2 secondary outcomes
Functional connectivity of the anterior mid cingulate cortex, the dorsolateral and medial prefrontal cortex and diffusion metrics of the corpus callosum and association fiber tracts of the temporal and frontal lobes
Time frame: 12 Weeks
Number of minutes walking per week and total number of steps per week
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.
- Individual participant dataSharing planned: No
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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 Planning, Reminders, and Micro-Incentives and Health Education in people with Traumatic Brain Injury and TBI, run by Timothy Morris 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 14 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?
Number of planned walks completed (time frame: 12 Weeks). 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.