Combining rehabilitation techniques to help individuals with traumatic brain injury
Randomized Controlled Trial of Combined Cognitive Rehabilitation and Exercise Training for Learning and Memory in Persons With Moderate to Severe Traumatic Brain Injury
This study is testing if combining a special memory training with aerobic exercise can help people with moderate-to-severe traumatic brain injury improve their memory and daily functioning.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT05716048 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining the Kessler Foundation modified Story Memory Technique® (KF-mSMT®) with aerobic exercise training (AET) to improve new learning and memory impairment (NLMI) in individuals with moderate-to-severe traumatic brain injury (TBI). The study employs a two-arm, parallel group, double-blind randomized controlled trial design to compare the outcomes of KF-mSMT® plus AET against KF-mSMT® plus stretching exercise training. The trial aims to assess improvements in memory performance, neural correlates, and daily life functioning for participants suffering from NLMI due to TBI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a diagnosis of moderate-to-severe TBI and documented new learning and memory impairment.
Not a fit: Patients with mild TBI or those who do not demonstrate significant memory impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance memory recovery and daily functioning for individuals with traumatic brain injury.
How similar studies have performed: While the combination of KF-mSMT® with aerobic exercise training is a novel approach, previous studies have shown moderate success with KF-mSMT® alone in improving memory in TBI patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Nancy D Chiaravalloti, PhD — Kessler Foundation
- Study coordinator: Nancy Moore, MA
- Email: nbmoore@kesslerfoundation.org
- Phone: 973-324.8450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.