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Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury

RecruitingPhase 1Ages 18 Years - 65 YearsAllKessler Foundation
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In plain words

What the trial is, and whether it could suit you

New learning and memory impairment (NLMI) is a common and devastating manifestation of TBI associated with substantial life burdens. Persons with moderate to severe TBI have shown improvement in NLM for prose material (e.g. story) as well as beneficial changes in default-mode network (DMN) activation during list-learning19 following treatment with the Kessler Foundation modified Story Memory Technique® (KF-mSMT®). Benefits, however, were moderate and did not yield downstream improvements in daily life. It is thus critical to examine other approaches to complement the KF-mSMT® for robustly managing NLMI in TBI. The proposed RCT will be the first to include aerobic exercise training (AET) as a highly-promising complement to the KF-mSMT® for robustly managing NLMI, examining impact on NLM, its neural correlates, and daily life in NLM impaired persons with moderate-to-severe TBI. We thus pro

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • KF-mSMT Plus Aerobic Exercise Training
  • KF-mSMT Plus Stretching Exercise Training
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Where

1 site
Kessler Foundation
West Orange, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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