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New treatment option for Traumatic Brain Injury
Official title Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury
ClinicalTrials.gov ID: NCT05716048
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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...
- Having significantly impaired vision by scotomas (corrected vision in worse eye worse than 20/60), diplopia, or nystagmus.
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.