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Recovery Among Older Adults Following Mild TBI

28 avril 2026 mis à jour par: University of Maryland, Baltimore
Among fall related injuries in older adults, head injuries are the most common, yet almost nothing is known about recovery from head injury, also known as traumatic brain injury or TBI, in this population. The RETRO-TBI study is a prospective cohort study of 250 adults aged 65 and older with mild TBI to evaluate recovery in cognitive, physical and psychological function and sleep quality at four timepoints (2 weeks and 3, 6, and 12 months) over the year following injury and identify factors associated with recovery trajectories. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform future development of strategies to optimize recovery following this common fall-related injury among older adults.

Aperçu de l'étude

Statut

Recrutement

Description détaillée

Development of Alzheimer's disease and related dementias (ADRD) is multifactorial, and some causal factors can be influenced or modified. Recently, the Lancet Commission included traumatic brain injury (TBI) in its list of 12 key potentially modifiable ADRD risk factors. TBI is a very common injury among older adults, resulting in over 123,000 hospitalizations and 485,000 emergency department visits annually. Importantly, rates of TBI are rapidly increasing in this population. TBI results in cognitive impairment and increases risk for both Alzheimer's disease and fronto-temporal dementia. Furthermore, TBI can result in worsened health outcomes (e.g., poor cognitive and physical functioning, psychological distress, worsened sleep quality), which in turn increase risk for ADRD. Yet, despite the large public health impact of TBI among older adults, little is known about changes in cognition and related domains following discharge from acute care in this population. Although such information is urgently needed to guide rehabilitation, care planning, and promotion of optimal long-term recovery in this vulnerable population, these data are severely lacking in the literature. One major reason for this lack of knowledge is that most prior research on TBI has focused on younger adults. Unfortunately, many findings from younger adults do not generalize to older adults due to their higher comorbidity burden and poorer cognitive and physical functioning at discharge from acute care. The objective of the proposed research is to gain an in-depth understanding of recovery of cognition, psychological and physical functioning, and sleep quality following TBI among older adults. To achieve this objective, the investigators propose to conduct a prospective cohort study of 250 patients aged 65 years and older treated for mild TBI at the R Adams Cowley Shock Trauma Center or at one of six University of Maryland Medical System affiliated hospitals with follow-up at 2 weeks and 3, 6, and 12 months to complete three Specific Aims: 1) Assess recovery of cognitive functioning and identify predictors of poor recovery; 2) Assess recovery of physical and psychological functioning and sleep quality and identify predictors of poor recovery; 3) Identify interactions between recovery trajectories.

The significance of this research is that it will identify unique recovery patterns across important domains of functioning (including cognitive function) and factors that impact the course of recovery following mild TBI among older adults. Identification of individuals at risk for poor cognitive recovery following TBI will highlight a population at high risk of ADRD and would permit targeting those individuals with cognitive rehabilitation interventions, potentially reducing ADRD risk. The rationale for the proposed study is that early identification of patients with poorer recovery trajectories will permit development and targeting of appropriately timed interventions to mitigate ADRD risk and other adverse outcomes. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform development of a geriatric-TBI focused rehabilitation intervention that will be the focus of a future R01 application.

Type d'étude

Observationnel

Inscription (Estimé)

250

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • Recrutement
        • University of Maryland, Baltimore
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jennifer Albrecht, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Study population consists of adults aged 65 or older who live within 55 miles of the University of Maryland Medical Center and who have been treated for a mild traumatic brain injury at a participating emergency department within 72 hours of injury.

La description

Inclusion Criteria

  • Aged 65 years or older
  • Treated for mild TBI (defined below) at the R Adams Cowley Shock Trauma Center (STC) or at one of six University of Maryland Affiliated Hospitals within 72 hours of injury
  • Mild TBI was defined as:

    • Traumatically induced physiological disruption of brain function, as manifested by at least one of the following 1) loss of consciousness ≤30 minutes, post-traumatic amnesia <24 hours, observed or self-reported transient confusion, disorientation, or impaired consciousness, or neurologic deficit as defined by a Glasgow Coma Scale (GCS) score of 13-14 on admission.
    • GCS of 15 with no other evidence of mild TBI was also accepted with positive computed tomography image.

Exclusion criteria

  • Injury to any other body region resulting in an abbreviated injury scale (AIS) score >2
  • Anticipation that patient would not be ambulatory at 2-weeks post-injury
  • History of dementia as determined by patient/proxy report or medical history
  • Non-ambulatory pre-injury
  • No available proxy
  • Not English speaking
  • Prisoners
  • Live >55 miles from the STC.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Physical function
Délai: 2 weeks, 3, 6, and 12 months
Short Physical Performance Battery total score. Range 0-12, Higher scores indicating better lower extremity function
2 weeks, 3, 6, and 12 months
Cognition
Délai: 2 weeks, 3, 6, and 12 months
Repeatable Battery for the Assessment of Neuropsychological Status total scaled score. The scaled score is age adjusted with a mean of 100 and a standard deviation of 15. Scores below 100 indicate poorer cognitive function relative to same-age peers.
2 weeks, 3, 6, and 12 months
Sleep quality
Délai: 2 weeks, 3, 6, and 12 months
Sleep duration in hours obtained from averaging values from participant's 1-week sleep diary. Healthy sleep duration for older adults ranges between 7-8 hours per night.
2 weeks, 3, 6, and 12 months
Psychological function
Délai: 2 weeks, 3, 6, and 12 months
Geriatric depression scale, 15-item version. Range 0-15 with higher scores indicating more severe symptoms of depression.
2 weeks, 3, 6, and 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Physical Function
Délai: 2 weeks, 3, 6, and 12 months
The Four-Step Square Test, measured as the number of seconds needed to complete the test. Values greater than 15 seconds are associated with increased fall risk.
2 weeks, 3, 6, and 12 months
Physical Function
Délai: 2 weeks, 3, 6, and 12 months
Activities of Daily Living, range 0-6 with higher scores indicating increased independence in activities of daily living
2 weeks, 3, 6, and 12 months
Physical Function
Délai: 2 weeks, 3, 6, and 12 months
Instrumental Activities of Daily Living, range 0-8 with higher scores indicating independence in instrumental activities of daily living
2 weeks, 3, 6, and 12 months
Physical Function
Délai: 2 weeks, 3, 6, and 12 months
Glasgow Outcomes Scale Extended, range 1-8 with higher scores indicating better recovery following traumatic brain injury
2 weeks, 3, 6, and 12 months
Cognition
Délai: 2 weeks, 3, 6, and 12 months
Repeatable Battery for the Assessment of Neuropsychological Status domain scores (delayed memory, immediate memory, visuo-spatial, language, attention). The scaled score is age adjusted with a mean of 100 and a standard deviation of 15. Scores below 100 indicate poorer cognitive function relative to same-age peers
2 weeks, 3, 6, and 12 months
Sleep Quality
Délai: 2 weeks, 3, 6, and 12 months
Insomnia Severity Index, range 0-28 with higher scores indicating increased symptoms of insomnia
2 weeks, 3, 6, and 12 months
Sleep Quality
Délai: 2 weeks, 3, 6, and 12 months
Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating poorer sleep quality
2 weeks, 3, 6, and 12 months
Psychological Function
Délai: 2 weeks, 3, 6, and 12 months
Hospital Anxiety and Depression Scale (anxiety sub-scale), range 0-21 with higher scores indicating increased symptoms of anxiety
2 weeks, 3, 6, and 12 months
Psychological Function
Délai: 2 weeks, 3, 6, and 12 months
Rivermead post-concussion symptoms questionnaire, range 0-64 with higher scores indicating more severe post-concussive symptoms.
2 weeks, 3, 6, and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Jennifer Albrecht, PhD, University of Maryland

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 mai 2023

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

1 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Deidentified data from RETRO-TBI will be shared with eligible researchers after completion of study aims upon approval of a proposal including an analytic plan. Interested researchers should contact the PI for additional information.

Délai de partage IPD

Start Date: 1/1/31. No end date.

Critères d'accès au partage IPD

Interested researchers should contact the PI after the availability date and will be asked to submit a proposal for use of the data including an analytic plan.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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