Concussion Treatment in Older Adults

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Although concussion is a common occurrence in older adults, we know little about the injury in this at-risk population. Certain management tools that might be appropriate for adolescent and young adult populations may not be appropriate for use in older adults who may have sensory, cognitive, and neuro-motor limitations. This study will help to develop initial evidence for targeted treatments for concussion in older adults. The study will utilize a two group design with permuted block random assignment to intervention and usual care/control groups. All participants will complete the following assessments at their initial and follow-up visit appointments: cognitive screening (learning, memory, language, executive functioning), concussion and mood symptom questionnaires, and neuro-motor screening. The primary outcomes for this study will be total symptom severity score (i.e., symptom burden) on the Concussion Clinical Profiles Screening (CP Screen) and Patient Global Impression of Change (PGIC). Secondary outcomes will include: Short Falls Efficacy Scale (SFES), Dizziness Handicap Inventory (DHI), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15 (PHQ-15), Generalized Anxiety Disorder - 7 (GAD-7), Posttraumatic Stress Disorder Checklist (PCL-5), Pittsburgh Sleep Quality Index (PSQI), Neuro-Quality of Life (QOL) v2.0 - Cognition Function (Short version), Headache Impact Test (HIT-6), ID Migraine, Neck Disability Index (NDI), Vestibular Ocular Motor Screen (VOMS), Timed-Up-and-Go (TUG), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). All outcomes will be treated as continuous. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05849064
Study type	Interventional
Source	University of Pittsburgh
Contact	Anthony Kontos, PhD
Phone	412-432-3725
Email	akontos@pitt.edu
Status	Recruiting
Phase	N/A
Start date	September 7, 2023
Completion date	December 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.