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Behavioural Intervention

Planning and Incentives for Traumatic Brain Injury

N/A
Recruiting
Research Sponsored by Northeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 65-80 years
No brain bleeds
Must not have
Not fluent in English
Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular events
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the effectiveness of a planning, reminders, and micro-incentives intervention to regular health education on increasing physical activity in older adults who have previously experienced a non-penetrating

Who is the study for?
This trial is for older adults who have had a mild or moderate non-penetrating traumatic brain injury (TBI). They must be able to exercise, not on central nervous system medications, and willing to attend baseline testing at Northeastern University. Specific inclusion and exclusion criteria details were not provided.
What is being tested?
The study compares the effectiveness of a special program with planning, reminders, and small rewards against standard health education in increasing physical activity over 12 weeks. Participants will use FitBit trackers and record their walking activities.
What are the potential side effects?
Since this trial involves non-medical interventions like planning assistance, reminders, micro-incentives, and health education rather than drugs or invasive procedures, significant side effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 65 and 80 years old.
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I have not had any bleeding in my brain.
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I have not been diagnosed with a neurological disease.
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I can walk without pain or help from devices.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not fluent in English.
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I am currently being treated for a heart condition or blood clot.
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I have had a severe brain injury or skull damage.
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I have never had sudden fainting spells or constant dizziness.
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I have had a stroke or brain bleed in the past.
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I have a neurological condition like MS, Parkinson's, or dementia.
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I have a severe disability or chronic condition like asthma, epilepsy, or kidney disease.
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I have not had a heart attack or any heart surgery in the last year.
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I regularly use a device to help me walk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Planning, Reminders, and Micro-IncentivesExperimental Treatment1 Intervention
Group II: Health EducationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Brandeis UniversityOTHER
21 Previous Clinical Trials
13,867 Total Patients Enrolled
Northeastern UniversityLead Sponsor
98 Previous Clinical Trials
70,936 Total Patients Enrolled
~22 spots leftby Mar 2025
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