Clinical trial NCT05849064: Concussion Treatment in Older Adults
Official title: Randomized Controlled Trial of Targeted Treatment in Older Adults Following Concussion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Mild
Keywords: concussion
mild traumatic brain injury
treatment
older adults
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives basic behavioral management strategies. The second group gets targeted treatment strategies dependent on the concussion symptoms they are expressing.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 50 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

Exclusion Criteria:

* Diagnosed neurological disorder (stroke, dementia, epilepsy)
* Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)
* Diagnosed with moderate to severe brain injury or past brain surgery/malformations

Primary outcomes:
measure: Concussion Clinical Profiles Screening (CP Screen)
timeFrame: Visit 1 (Baseline)
measure: Concussion Clinical Profiles Screening (CP Screen)
timeFrame: At study completion, an average of 30 days after Visit 1
Secondary outcomes:
measure: Vestibular/Ocular Motor Screening (VOMS)
timeFrame: Visit 1 (Baseline)
measure: Vestibular/Ocular Motor Screening (VOMS)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Short Falls Efficacy Scale (SFES)
timeFrame: Visit 1 (Baseline)
measure: Short Falls Efficacy Scale (SFES)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Visit 1 (Baseline)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Visit 1 (Baseline)
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Visit 1 (Baseline)
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: PCL-5
timeFrame: Visit 1 (Baseline)
measure: PCL-5
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Neuro-QOL (Cognitive Function Scale - short form)
timeFrame: Visit 1 (Baseline)
measure: Neuro-QOL (Cognitive Function Scale - short form)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Visit 1 (Baseline)
measure: Dizziness Handicap Inventory (DHI)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Headache Impact Test-6 (HIT-6)
timeFrame: Visit 1 (Baseline)
measure: Headache Impact Test-6 (HIT-6)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: ID Migraine
timeFrame: Visit 1 (Baseline)
measure: ID Migraine
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Visit 1 (Baseline)
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Neck Disability Index
timeFrame: Visit 1 (Baseline)
measure: Neck Disability Index
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Visit 1 (Baseline)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Timed-Up-and-Go
timeFrame: Visit 1 (Baseline)
measure: Timed-Up-and-Go
timeFrame: At study completion, an average of 30 days after Visit 1
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Daily between Visit 1 and study completion, an average of 30 days
measure: Percent Back to Normal
timeFrame: Daily between Visit 1 and study completion, an average of 30 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anthony Kontos, PhD
role: PRINCIPAL_INVESTIGATOR
References: