Concussion Treatment in Older Adults

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05849064
Status
Recruiting
Apply to this trial

Conditions

  • Concussion, Mild

Eligibility Criteria

Sex
ALL
Age
50 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Control — BEHAVIORAL
    Participants will receive standardized behavioral management strategies for their concussion symptoms including: activity, hydration, nutrition, sleep, and stress management strategies. These strategies provide general methods to manage concussion symptoms and regulate daily activities to assist in the recovery of concussion.
  • Targeted Intervention — BEHAVIORAL
    Participants will be prescribed one or more interventions, tailored to their domains. Anxiety/Mood-Cog beh therapy(CBT) for maladaptive beliefs/avoidance/coping behaviors. Graded exposure/activity/relaxation exercises, cognitive restructuring. Cognitive-Accommodations for reduced work/school time/delayed deadlines, more frequent/longer cognitive rest during symptom-provoking activities. Migraine/Headache: Education, relaxation training/mindfulness based therapy. Ocular-Exercises for ocular symptoms, near point convergence, may include Brock string, pencil push-ups, fixation, saccade tracking, pursuits. Sleep-Sleep regulation/hygiene. Mindfulness-based training, morning physical activity, CBT.Vestibular-Exercises for dizziness, visual motion sensitivity, gait, imbalance that may include gaze stability, visual habituation, static and dynamic balance/gait.

Study Details

The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.

Key Dates

Start date
Sep 7, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Behavioral Control
    Participants randomized to the behavioral control group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies.
  • Experimental: Targeted Intervention
    Participant receives exercises or strategies based on their clinical concussion domain given to them by their neuropsychologist: 1) Anxiety/Mood, 2)Headache/Migraine, 3)Vestibular, 4)Ocular, 5)Cognitive.

Primary Outcome Measure

Concussion Clinical Profiles Screening (CP Screen) [ Time Frame: Visit 1 (Baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15203
Anthony P Kontos, PhD
[email protected]
412-432-3725
Courtney Perry, MS
[email protected]
412-904-1298
Anthony P Kontos, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pittsburgh· Pittsburgh, PA

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