Combining rehabilitation techniques to help individuals with traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PIONEER-Prognosis: Using biomarkers and wearables to forecast recovery after mild traumatic brain injury

  This study tests whether blood biomarkers, health data from records, and wearables can help predict how people recover after a mild traumatic brain injury treated in the emergency department.

  Recruiting at 3 sites University of Michigan · Torrance, California and 4 other locations · NCT07858266

• HBOT to see if it helps cognition and well‑being in first responders with prior brain injury

  This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07852728

• Depth Electrode Monitoring after Traumatic Brain Injury

  This study tests adding a depth electrode with continuous brain monitoring during external ventricular drain placement in adults with traumatic brain injury to see if cortical reverberation signals can be tracked safely.

  Recruiting Hennepin Healthcare Research Institute · Minneapolis, Minnesota · NCT07842458

• Understanding growth hormone deficiency after a brain injury in adults

  This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.

  Recruiting University of Calgary · Calgary, Alberta and 1 other locations · NCT07795736

• Electrical stimulation-assisted exercise for people with lower limb paralysis

  This study tests whether adding electrical stimulation during exercise can improve leg muscle strength and endurance for people with paralysis.

  Recruiting Louis Stokes VA Medical Center · Cleveland, Ohio · NCT07768761

• ZEPU-2000 robotic rehab for arm and leg weakness

  This trial tests whether adding ZEPU-2000A, ZEPU-2000D, and ZEPU-2000E robotic rehabilitation to usual therapy helps adults with arm/leg movement problems from stroke, incomplete SCI, TBI, or related conditions.

  Recruiting Bangladesh Medical University · Dhaka · NCT07749612

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.