Can exercise and brain training fix memory after a head injury?

NCT ID NCT05716048

Symptom relief Sponsor: Kessler Foundation Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at whether combining a memory-training program with aerobic exercise can help people with moderate to severe traumatic brain injury (TBI) improve their learning and memory. Sixty adults with TBI will be randomly assigned to either memory training plus aerobic exercise or memory training plus stretching. The goal is to see if adding exercise leads to better memory, brain changes, and daily functioning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: cognitive rehabilitation (KF-mSMT) plus aerobic exercise training
What this could lead to: If it works, this could offer a new, non-drug way to improve memory and daily life for people with traumatic brain injury.
What could go wrong: This is a small, early-phase trial (60 people) testing a behavioral intervention, so results may not apply broadly. The benefit may be modest or not translate to real-world improvements.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can exercise and brain training fix memory after a head injury?

What the study statuses mean