- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549532
Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI) (T-MD)
Multisite Randomized Controlled Trial of Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anthony P Kontos, PhD
- Phone Number: 412-432-3725
- Email: akontos@pitt.edu
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh
-
Contact:
- Anthony P Kontos, PhD
- Phone Number: 412-432-3725
- Email: akontos@pitt.edu
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Contact:
- Cyndi Holland, MPH
- Phone Number: 412-904-1298
- Email: clh197@pitt.edu
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Principal Investigator:
- Michael W Collins, PhD
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Sub-Investigator:
- Patrick Sparto, PhD
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Sub-Investigator:
- Alicia Trbovich, PhD
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Sub-Investigator:
- David O Okonkwo, MD/PhD
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Sub-Investigator:
- Ryan Soose, MD
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Sub-Investigator:
- Anne Mucha, DPT
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Sub-Investigator:
- Victoria Kochick, DPT
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Sub-Investigator:
- Theodore Huppert, PhD
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Virginia
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Fairfax, Virginia, United States, 22031
- Recruiting
- Inova Health System - Inova Sports Medicine Concussion Program
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Contact:
- Melissa Womble, PhD
- Phone Number: 703-970-6427
- Email: Melissa.Womble@inova.org
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Contact:
- RJ Elbin, PhD
- Phone Number: 479-575-5262
- Email: rjelbin@uark.edu
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: Participants must meet ALL of the following inclusion criteria:
- 18-49 years of age
- Normal/corrected vision
- Diagnosed with complex mTBI in the past 8 days-6 months with clear mechanism of injury
- Glascow coma scale (GCS) score no less than 13
- Reported or sign of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting
- Complex mTBI-related symptoms and/or impairments in at least one of the following areas: anxiety/mood, cognitive, migraine, ocular, vestibular, sleep, autonomic; per a comprehensive assessment, clinical exam/interview, and adjudication process.
Exclusion Criteria: Participants will be excluded if they meet one or more of the following exclusion criteria:
- History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral, or bilateral vestibular hypofunction)
- History of neurological disorder
- Previous moderate to severe TBI
- History of brain surgery, malformations or tumors
- Diagnosed with cardiac, peripheral or cerebrovascular disease
- Experienced chest pain or shortness of breath while at rest or with mild exertion
- Been told by a doctor to only conduct physical activity under medical supervision
- Previous moderate to severe TBI
- < 8 days or >6 months following current complex mTBI
- Currently pregnant or become pregnant during study
- Currently involved in litigation associated with current or previous mTBI
- Currently on workman's compensation
- Previously participated in the study
Previously received treatment at either site within last two years as this will unblind treatment group(s)
Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.
- Please note that participants with a history of mTBI, ADHD/LD, migraine, or motion sickness will NOT be excluded. We will adjust for any imbalance in the groups on these factors via covariate analysis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T-MD Intervention Group
Participants will be prescribed 1+ interventions tailored to affected 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.Autonomic-Graded aerobic exercise.
Perform daily aerobic exercise, goal 80% HR max on a stationary bike/treadmill/walking/jogging.
|
Participants in the T-MD intervention group will be prescribed targeted interventions to address each individual's symptoms, impairments, and functional limitations in the areas of anxiety/mood, cognitive, migraine/headache, ocular, vestibular, sleep, autonomic.
The length of the intervention period will be 4 weeks or until RTA, whichever comes first.
|
Active Comparator: Behavioral Management
Participants in control group will receive standardized behavioral management strategies 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.
Clinicians will discuss and review a behavioral strategies handout with each participant and answer any questions they may have about the information in the handout.
Contact time between clinicians and patients will be similar to avoid effects associated with more or less contact time.
|
1.3.
Usual Care (Controls) Group Participants randomized to the usual care (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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurobehavioral Symptom Inventory (NSI)
Time Frame: NSI will be measured from baseline to 3 months.
|
NSI is a 22 item symptom scale, participants will rate the severity of their symptoms on a 5 point likert scale (0, none/rarely ever present to 4, very severe, almost always present).
The NSI total score is a sum of the 22 items (range 0-88).
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NSI will be measured from baseline to 3 months.
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Patient Global Impression of Change (PGIC)
Time Frame: The PGIC will be measured from baseline to 3 months.
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PGIC is a self-reported assessment of change.
Participants rate their impression of how much better they feel on a 7 point likert scale.
It is a 1 item survey, with higher scores representing no change and associated with feeling worse.
(Responses 1=much improved, 2=minimally improved, 3=no change, 4=minimally worse, 5=much worse, 6=very much worse).
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The PGIC will be measured from baseline to 3 months.
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Functional Near-infrared Spectroscopy (fNIRS)
Time Frame: fNIRS will be conducted two times, once baseline and again at the 4 week visit.
|
fNIRS will be used to record changes in oxygenated hemoglobin (activation) and deoxygenated hemoglobin (deactivation) in participants.
fNIRS will assess 3 broad regions of interest: left and right temporal, occipital.
It will measure bilateral areas of the inferior frontal, dorsal-lateral prefrontal, and frontal regions of the brain including Brodmann areas as well as the middle frontal gyrus, superior temporal gyrus, and extrastriate visual cortical regions.
fNIRS will be done in 2 different paradigms: 1) at rest, and 2) during cognitive activity.
At rest measurements will occur while participants are seated, and last about 2 minutes.
For the cognitive activity, participants will perform the ImPACT test while wearing the fNIRS unit, and last 20 minutes.
We will compare brain activation and deactivation in ROIs across the two points and between rest and cognitive activity paradigms.
We will also examine task specific changes within the cognitive test paradigm.
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fNIRS will be conducted two times, once baseline and again at the 4 week visit.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral Symptom Inventory (BSI-18)
Time Frame: The BSI-18 will be measured from baseline to 3 months.
|
The BSI is an 18 item symptom inventory that assesses the level of psychological distress during the past 7 days.
Responses are on a 5 point Likert scale (0=not at all - 4 = extremely).
The BSI-18 yields total global severity index ranging from 0-72, as well as somatic, depression and anxiety sub-scales.
Higher scores indicate higher levels of psychological distress.
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The BSI-18 will be measured from baseline to 3 months.
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Dizziness Handicap Inventory (DHI)
Time Frame: The DHI will be measured from baseline to 3 months.
|
The DHI is a 25 item self-reported measure that examines dizziness-related handicap.
The assessment has 3 domains (functional, emotional, and physical).
Participants self-report the level dizziness has impacted their abilities in the 3 domains with each domain having 9 questions (questions are answered No (0)/Sometimes(2)/Yes(4)) Item scores are summed.
There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional).
Minimum score is 0.
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The DHI will be measured from baseline to 3 months.
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Vestibular Ocular Motor Screening (VOMS)
Time Frame: VOMS will be will be measured from baseline to 4 weeks.
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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.
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VOMS will be will be measured from baseline to 4 weeks.
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Modified Balance Error Scoring System (mBESS)
Time Frame: mBESS will be measured from baseline to 4 weeks.
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The mBESS measures postural stability and consists of three stances including feet side by side, a tandem stance, and a single-leg stance on the non-dominant leg.
The three stances are performed for 20 seconds each and completed with eyes closed and hand on the iliac crests.
Errors include lifting hands off the iliac crests, opening the eyes, stepping, stumbling, or falling, moving the hip into more than a 30 degree of flexion or abduction, lifting the forefoot or heel, or remaining out of the testing position for more than 5 seconds.
Each error equals 1 point, with higher scores indicating worse performance.
Score ranges from 0-30 (maximum of 10 errors per each stance).
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mBESS will be measured from baseline to 4 weeks.
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Functional Gait Assessment (FGA)
Time Frame: The FGA will be measured from baseline to 4 weeks.
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FGA is 10 items that assesses the ability of participants to walk with head turns, changes of speed of walking, and walking around obstacles.
Each item is scored on a 4 point ordinal scale; 0 (severe impairment), 1 (moderate impairment), 2 (mild impairment), 3 (normal ambulation).
Score range is 0-30.
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The FGA will be measured from baseline to 4 weeks.
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Clinical Profile Screening Inventory (CP Screen)
Time Frame: The CP screen will be measured from baseline to 3 months.
|
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.
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The CP screen will be measured from baseline to 3 months.
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Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)
Time Frame: ImPACT will be administered at baseline, 2 week, 4 week visits.
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ImPACT will be used to assess neurocognitive performance.
ImPACT is a computerized neurocognitive test that includes 6 modules: 1) verbal memory, 2) design memory, 3) X's and O's, 4) symbol matching, 5) color matching, and 6) three letter memory.
These modules are used to form/score four composite scores - verbal and visual memory 5), visual motor processing speed 6), and reaction time (seconds).
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ImPACT will be administered at baseline, 2 week, 4 week visits.
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: The PSQI will be measured from baseline to 3 months.
|
The PSQI assesses sleep quality.
It is an 19 item self-reported measure that is comprised of seven component scores: 1) subjective sleep quality, 2) sleep latency, 3) sleep duration, 4) sleep efficiency, 5) sleep disturbances, 6) sleep medication usage, and 7) daytime dysfunction.
Each item is scored 0-3 (0 = very good, 1 = fairly good, 2= fairly bad, 3=very bad).
Higher scores indicate more sleep dysfunction.
Score range is 0-21.
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The PSQI will be measured from baseline to 3 months.
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Headache Impact Test (HIT-6)
Time Frame: The HIT-6 will be measured from baseline to 3 months.
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The HIT-6 is comprised of 6 self-report items that assess frequency, severity and limitations of daily activities, fatigue, irritability, and concentration related to headaches.
Items score from 6 to 13, with higher scores indicating worse severity.
Scores = never = 6pts, rarely = 8 pts, sometimes = 10pts, very often = 11 pts, always = 13 points.
Score range 36-78.
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The HIT-6 will be measured from baseline to 3 months.
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ID Migraine
Time Frame: ID Migraine will be measured from baseline to 3 months.
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The ID Migraine will be used to screen for headache symptoms.
It is a 3 item screening tool designed to assess presence (yes/no) of symptoms related to headache/migraine pain.
Scores range from 0-3 with clinical cut-off of 2+ indicating presence of migraines.
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ID Migraine will be measured from baseline to 3 months.
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Short Form McGill Pain Questionnaire (SF-MPQ)
Time Frame: The SF-MPQ will be measured from baseline to 3 months.
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The SF-MPQ is a 15 item pain scale in which participants rate the intensity of their pain on a 4 point likert scale 0 (none) to 3 (severe).
The assessment has two subscales (sensory and affective).
Higher scores indicate higher pain.
Score range 0-75.
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The SF-MPQ will be measured from baseline to 3 months.
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International Physical Activity Questionnaire (IPAQ)
Time Frame: The IPAQ will be measured from baseline to 3 months.
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The International Physical Activity Questionnaire (IPAQ) will be used to assess potential treatment group differences in activity level.
The IPAQ is a validated tool to assess recall of average activity level and intensity over the preceding 7 days.
Activity levels can be expressed as categorical variables (low, medium, high activity levels) or a continuous variable (MET-minutes/week).
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The IPAQ will be measured from baseline to 3 months.
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Buffalo Concussion Treadmill Test (BCTT)
Time Frame: The BCTT will be completed at 2 study timepoints (baseline and 4 weeks).
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The BCTT will be used in this study to measure autonomic dysfunction of participants' following mTBI.
Prior to test initiation, resting heart rate (HR) is measured after a 2 minute seated resting period.
A visual analog scale is used to rate symptoms at baseline.
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The BCTT will be completed at 2 study timepoints (baseline and 4 weeks).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony P Kontod, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO20050029
- W81XWH2010745 (Other Grant/Funding Number: US Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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