Concussion Treatment in Older Adults
ConditionConcussion, Mild
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-99
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)
Diagnosed with moderate to severe brain injury or past brain surgery/malformations
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral Control
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Behavioral ControlActive comparator 1 intervention
Group B: Targeted InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Visit 1 (Baseline)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.
Time frame
At study completion, an average of 30 days after Visit 1Secondary outcomes
1
Vestibular/Ocular Motor Screening (VOMS)
The VOMS assesses impairment via patient report symptom provocation following each of 5 test components (smooth pursuits, horizontal/vertical saccades, convergence, horizontal and vertical vestibular ocular reflex (VOR) and visual motor sensitivity (VMS). Patients verbally rate changes in headache, dizziness, nausea, and fogginess after each test, as well as report their baseline symptoms. Symptoms in each area are rated on scale 0 (none) to 10 (severe). Scores on any VOMS item of 2+ reflects a positive screening cut-off for vestibular and/or ocular motor impairment.
Time frame
Visit 1 (Baseline)2
Vestibular/Ocular Motor Screening (VOMS)
The VOMS assesses impairment via patient report symptom provocation following each of 5 test components (smooth pursuits, horizontal/vertical saccades, convergence, horizontal and vertical vestibular ocular reflex (VOR) and visual motor sensitivity (VMS). Patients verbally rate changes in headache, dizziness, nausea, and fogginess after each test, as well as report their baseline symptoms. Symptoms in each area are rated on scale 0 (none) to 10 (severe). Scores on any VOMS item of 2+ reflects a positive screening cut-off for vestibular and/or ocular motor impairment.
Time frame
At study completion, an average of 30 days after Visit 13
Short Falls Efficacy Scale (SFES)
The SFES is a 7 item survey that measures a subject's fear and concerns about falling during normal daily life activities. Question responses are scaled from 1-4, with higher scores indicating more concern for falls. (Low concern = 7-8; Moderate concern = 9-13; High concern = 14-28).
Time frame
Visit 1 (Baseline)4
Short Falls Efficacy Scale (SFES)
The SFES is a 7 item survey that measures a subject's fear and concerns about falling during normal daily life activities. Question responses are scaled from 1-4, with higher scores indicating more concern for falls. (Low concern = 7-8; Moderate concern = 9-13; High concern = 14-28).
Time frame
At study completion, an average of 30 days after Visit 1Sponsors and contacts
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Source ClinicalTrials.gov