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Rehabilitation for Traumatic Brain Injury

This study is looking at new ways to help people with traumatic brain injury (TBI) who have trouble with learning and memory. Researchers are testing two different approaches: one combines KF-mSMT (a memory technique) with aerobic exercise, and the other combines KF-mSMT with stretching exercises. Participants will receive one of these combined treatments three days a week for 12 weeks. The main goal is to see if these treatments improve memory, specifically how well you perform on the California Verbal Learning Test-3. This study aims to enroll 60 adults between 18 and 65 years old who have had a moderate-to-severe TBI at least one year ago and are not very physically active. The current status of this study is unclear.

Study design
This interventional study plans to enroll 60 participants to test two different behavioral interventions.
What's involved
You would participate in a combined intervention three days a week for 12 weeks. Each session would start at 15 minutes and gradually increase to up to 2 hours.
Compensation
Not stated in the trial record.
Follow-up
Your memory performance will be measured from the start of the study up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05716048

Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Kessler Foundation
~60 participants
Updated 2025-09-04 on ClinicalTrials.gov
What's tested:KF-mSMT Plus Aerobic Exercise TrainingKF-mSMT Plus Stretching Exercise Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in California Verbal Learning Test-3 Performance
Measured over From 0 to 12 weeks

Conditions

Traumatic Brain Injury

Explore related trials

Traumatic Encephalopathy

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Nancy D Chiaravalloti, PhD · PRINCIPAL_INVESTIGATOR · Kessler Foundation

Who to contact

Nancy Moore, MA
[email protected]
973-324.8450
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Age between 18-65 to control for age related brain changes
Diagnosis of moderate-to-severe TBI based on TBIMS criteria at least one year prior to enrollment
Having no to low substance use / involvement (drug/alcohol) as documented via ASSIST
Being insufficiently physically active based on a Godin Leisure-Time Exercise Questionnaire Health Contribution Score of \<14
Having a proficiency in the English language
Being right handed to control for brain organization
Having chronic medical conditions (e.g. diabetes) in addition to TBI will require approval to participate from a physician, consistent with PAR-Q+.
Having an in-tact ability to follow directions based on the Telephone Interview for Cognitive Status (TICS-M) (i.e., TICS-M scores of ≥18)
Demonstrating new learning and memory impairment based on Open-Trial Selective Reminding Task (OT-SRT) scores at least 1.5 standard deviations below healthy controls (8+ trials to reach criterion)

Exclusion

Regularly taking steroids \& benzodiazapines to control for medications effects
Having a history of neurological disorders beyond TBI
Having a history of severe mental illness (e.g., schizophrenia, bipolar, severe major depression)
Having metal in the body, claustrophobia, and other risk factors that would make MRI scanning unsafe.
Having moderate or high risk for exercise training contraindications (e.g. diabetes), defined as ≥1 YES on pages 2-3 of the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
Having significantly impaired vision by scotomas (corrected vision in worse eye worse than 20/60), diplopia, or nystagmus.

What this trial measures

  • Change in California Verbal Learning Test-3 PerformanceFrom 0 to 12 weeks

    This is a test of new learning and memory