Concussion Treatment in Older Adults

NCT05849064 | Recruiting

• 1 other identifier: STUDY23020055
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Concussion, Mild

Keywords

concussion; mild traumatic brain injury; treatment; older adults

Outcome Measures

Primary Outcomes (2)

• Concussion Clinical Profiles Screening (CP Screen)

  The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.

  Visit 1 (Baseline)

• Concussion Clinical Profiles Screening (CP Screen)

  The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.

  At study completion, an average of 30 days after Visit 1

Secondary Outcomes (30)

• Vestibular/Ocular Motor Screening (VOMS)

  Visit 1 (Baseline)

• Vestibular/Ocular Motor Screening (VOMS)

  At study completion, an average of 30 days after Visit 1

• Short Falls Efficacy Scale (SFES)

  Visit 1 (Baseline)

• Short Falls Efficacy Scale (SFES)

  At study completion, an average of 30 days after Visit 1

• Patient Health Questionnaire-9 (PHQ-9)

  Visit 1 (Baseline)

Study Arms (2)

Behavioral Control

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Control

Targeted Intervention

EXPERIMENTAL

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.

Behavioral: Targeted Intervention

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.

Behavioral Control

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.

Targeted Intervention

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosed concussion within the last 4 days - 12 months
• Must be recruited at their initial concussion appointment
• Ability to read/write to complete study assessments/testing

You may not qualify if:

• Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)
• Diagnosed with moderate to severe brain injury or past brain surgery/malformations

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Interventions

Behavior Control

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Therapeutics; Behavioral Disciplines and Activities

Study Officials

• Anthony Kontos, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Kontos, PhD

CONTACT

412-432-3725; akontos@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: One group receives basic behavioral management strategies. The second group gets targeted treatment strategies dependent on the concussion symptoms they are expressing.

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 8, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)