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Randomized Controlled Trial for Vestibular Treatment in Concussion

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ClinicalTrials.gov Identifier: NCT03600324
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Anthony P. Kontos, Ph.D., University of Pittsburgh

Brief Summary:
A prospective, single-blind, four-group multi-center randomized controlled trial (RCT) of targeted rehabilitation exercises for vestibular symptoms and impairments (T-REV) in civilians with mild traumatic brain injury (mTBI) will be conducted at the University of Pittsburgh Medical Center Sports Medicine Concussion Program (UPitt). The four treatment groups will consist of the factorial combinations of low (30%) and high (70%) intensity of exercise crossed with low (12-18 min, 1x/day) and high (12-18 min, 2x/day) frequency. A total of 125 participants aged 18-40 years will be enrolled across years 1-4, with approximately 100 participants completing the whole study. After potential participants with mTBI are screened for the vestibular clinical profile, using domain-specific tests and measures, and enrolled into the study, participants will complete primary and secondary outcome measures and receive a home exercise program that a) targets participants individual deficits, and b) is of the appropriate intensity and frequency for the participant's randomly assigned treatment group. Participants will return for in-clinic visits once per week to receive treatment and progress assigned exercises.

Condition or disease Intervention/treatment Phase
Vestibular Disorder Mild Traumatic Brain Injury Behavioral: T-REV Not Applicable

Detailed Description:

During the past 17 years, US military personnel experienced 305,000 mTBI (DVBIC, 2017), with an estimated 65% (187,000) involving some type of vestibular impairment (gaze, postural/dynamic instability) and symptoms (dizziness, vertigo, motion intolerance) (Mucha et al., 2014). These vestibular impairments and symptoms, which have been associated with poor outcomes following mTBI including longer recovery times (Lau et al., 2011), can be actively treated using targeted vestibular rehabilitation exercises (Alsalaheen et al., 2010). In fact, the investigators recently concluded an observational trial of military personnel and civilians with mTBI- Targeted Evaluation, Action and Monitoring of TBI (TEAM-TBI) project (W81XWH-14-2-0002) supporting the effectiveness of targeted vestibular rehabilitation exercises in military personnel and civilians with complex mTBI (Kontos et al., in press). Although these vestibular-focused rehabilitation exercises are commonly used by military medical personnel following complex mTBI, there are no well-designed studies that show how much these exercises should be performed to be effective in US military personnel. In short, the concussion rehabilitation field does not know how frequently or intensely the exercises should be performed in order for injured personnel to have the best recovery.

In the current proposal, the investigators leverage our interdisciplinary team of experts from physical therapy, neurology, neuropsychology, and sports medicine and over 17 years of clinical and research experience to conduct a RCT comparing different frequency and intensity of targeted vestibular therapeutic exercises in military personnel and civilians. In so doing, the proposed study may inform a more precise approach for treating vestibular symptoms and impairments following mTBI that minimizes morbidity and accelerates recovery. Deliverables from the current study include: 1) outcome data regarding the efficacy of different frequencies and intensities of targeted vestibular exercises in both military personnel and civilians, and 2) evidence-based clinical practice guidelines (CPG) for prescribing vestibular therapeutic exercises.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A prospective, single-blind, four-group multi-center randomized controlled trial
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial for Vestibular Treatment in Concussion
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Intensity/Low Frequency
Participants will be assigned T-REV with low intensity (30% of perceived effort) and low frequency (exercises performed 1x/day)
Behavioral: T-REV
For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

Experimental: Low Intensity/ High Frequency
Participants will be assigned T-REV with low intensity (30% of perceived effort) and high frequency (exercises performed 2x/day)
Behavioral: T-REV
For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

Experimental: High Intensity/Low Frequency
Participants will be assigned T-REV with high intensity (70% of perceived effort) and low frequency (exercises performed 1x/day)
Behavioral: T-REV
For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

Experimental: High Intensity/High Frequency
Participants will be assigned T-REV with high intensity (70% of perceived effort) and high frequency (exercises performed 2x/day)
Behavioral: T-REV
For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.




Primary Outcome Measures :
  1. Dizziness Handicap Inventory [ Time Frame: enrollment, 2-week, 4-week, 3-month study visits ]
    The DHI is a 25-item self-report measure that examines dizziness-related handicap. Each item is categorized into one of three domains: functional, emotional, or physical. The DHI was developed with the help of patients who complained of dizziness and uses a three-item response scale (Yes, Sometimes, No) scored as 4/2/0, respectively. Score range: 0-100. The DHI has good internal consistency for the total score (alpha = 0.89). the test-retest reliability is high (r=0.97) and is response to change in a vestibular population. The DHI has been demonstrated to be valid in individuals with mTBI. The outcome measure will be assessed at multiple timepoints to assess change over time.


Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) [ Time Frame: enrollment, 2-week, 4-week, 3-month study visits ]
    The PGIC will be completed by all participants. The PGIC was developed for self-reported assessment of change resulting from post-concussion care at military treatment facilities. The prompt is: "Since beginning treatment at this facility, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life rated to your post-concussion condition?" The patient responds on a scale 0 (no change or condition has worsened) to 7 (considerable improvement). Because not all participants will have had a mTBI that precipitated the referral for physical therapy, the prompt will be modified to delete "post-concussive' for these cases. The interest for this measure is in the change between timepoints.

  2. Neurobehavioral Symptom Inventory (NSI) [ Time Frame: enrollment, 2-week, 4-week, 3-month study visits ]
    The NSI is a 22-item symptoms scale in which participants rate the severity of symptoms on a 5-point scale (0=none, 1= mild, 2=moderate, 3=severe, 4=very severe) Scores range from 0 to 60. The NSI takes approximately 5-10 minutes to administer. We are interested in the change in NSI over time.

  3. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) [ Time Frame: enrollment, 2-week, 4-week study visits ]
    The ImPACT will be used to assess neurocognitive performance in civilians. ImPACT is a computerized neurocognitive test that includes six 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 four composite cores: verbal and visual memories (%), visual motor processing speed (#), and reaction time (sec). The ImPACT takes 20-30 minutes to administer. The interest in ImPACT scores is in both each timepoint to assess cognitive performance against the normal for age and change between time points as an assessment of recovery.

  4. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: enrollment, 2-week, 4-week study visits ]
    The PSQI will be used to assess sleep quality and consists of an 18-item self-report 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. Scale for PSQI is 0 = not during past month; 1 = less than once a week; 2 = once or twice a week; 3 = three or more times a week. From the 18-item scores, seven component scores are calculated. A component score of 5 or greater is indicative of poor sleep quality. Sub-scale and global PSQI scores are calculated and higher scores indicating poorer sleep quality. The scores will be analyzed both at each timepoint to compare against normative values and between time points as an assessment of recovery.

  5. Identify (ID) Migraine [ Time Frame: enrollment, 2-week, 4-week study visits ]
    The ID Migraine is a 3-item screening tool designed to assess presence (yes/no) of symptoms related to headache/migraine pain including nausea, sensitivity to light, and functional impact of headaches. Scale for ID Migraine is 0 = no, 1 = yes. Scores range from 0-3 with clinical cut-off at 2 or greater indicating presences of migraine. The ID Migraine is both a valid and reliable screening tool for migraine with good combined sensitive and specificity. For the current study, we will adapt the ID Migraine tool by replacing the "during the last three months" time frame stem, with "following your injury". The ID Migraine requires 2 minutes to complete and score. he scores will be analyzed both at each timepoint to assess performance against clinical cutoffs and between time points as an assessment of recovery.

  6. Neck Pain Numerical Rating Scale (Neck Pain NRS) [ Time Frame: enrollment, 2-wk, 4-wk study visits ]
    The Defense and Veterans Pain Rating Scale (DVPRS) will be used specifically for neck pain. We will adapt the Defense and Veterans Pain Rating Scale (DVPRS) which was created to standardize pain reporting and measurement across the military. Changes to the verbal anchors include: 0 = "no dizziness", 1 = "hardly notice dizziness", 2 = "Notice dizziness, does not interfere with activities", 9 = "can't bear the dizziness, unable to do anything". Participants will be asked for their current and worst rating during the past week. A positive result will be indicated by a score of greater than 2 for current or worst rating, which indicates that the dizziness is starting to distract and interfere with activities. The Neck Pain NRS takes 1 minute to administer. The score will be analyzed both at each timepoint to assess current pain and compared over time to assess pain recovery.

  7. Behavioral Symptom Inventory-18 (BSI-18) [ Time Frame: enrollment, 2-week, 4-week study visits ]
    The BSI-18 is an 18-item symptom inventory that assesses the level of psychological distress during the past 7 days on 18 items. Symptoms are rated on a 5-point Likert scale ranging from 0 (not at all); 1 (a little bit); 2 (moderately); 3 (quite a bit); 4 (extremely). The BSI-18 yields total global severity index ranging from 0-72 as well as somatic, depression, and anxiety sub-scale scores. Any sub-scale T-score >63 is reflective of clinical impairment on that sub-scale. The BSI-18 requires 5 minutes to complete and score. Scores will be analyzed at each timepoint to assess current behavioral symptoms and impairments and compared over time to assess changes in symptoms.

  8. Return to Activity (RTA) [ Time Frame: 4-week, 3-month study visits ]
    Return to Activity will be medical clearance to resume full activities based on symptom and impairment free at rest, and symptom free following standardized exertion protocols per recent consensus. RTA will be assessed at 4 weeks and 3 months post-intervention.

  9. International Physical Activity Questionnaire (IPAQ) [ Time Frame: enrollment, 2-week, 4-week study visits ]
    The International Physical Activity Questionnaire (IPAQ) will assess potential treatment group difference in activity level. The IPAQ is a validated tool to assess recall of average activity level and intensity over the preceding 7 days. The IPAQ will be completed via text/online survey at 7 and 21 days and in person at 14 and 28 days during the clinic visits. The IPAQ was chosen because it is brief and can be either self-administered or administered via structured interview. Activity levels can be expressed as categorical variables (low, medium, high activity levels) or a continuous variable (MET-min/week). The IPAQ takes approximately 5 minutes to complete. Data will be analyzed at each timepoint and over time to assess changes in physical activity.

  10. Visual Vertigo Analog Scale (VVAS) [ Time Frame: 2-week, 4-week study visits ]
    The VVAS assesses how much dizziness 0 (none) to 10 (severe), on a visual analog scale, an individual reports for 9 different activities, such as walking through a supermarket aisle, being in a room with fluorescent lights, doing down and escalator, walking over a patterned floor, etc. A positive result occurs when an individual rates at least two of the nine items of the VVAS above zero (VVAS positive). The VVAS takes 5 minutes to administer. We will assess VVAS data at each timepoint and over time.

  11. Vestibular Ocular Motor Screening (VOMS) [ Time Frame: 2-wk, 4-wk study visits ]
    The VOMS assesses impairment via patient-reported symptom provocation following each of the following components: 1) smooth pursuits; 2) horizontal and vertical saccades; 3) convergence; 4) horizontal and vertical ocular reflex (VOR); and 5) visual motion sensitivity (VMS). Patients rate changes in headache, dizziness, nausea, and fogginess compared to their immediate pre-assessment state on a scale of 0 (none) to 10 (severe) to determine if any domain provokes symptoms. Scores on any VOMS item of 2 or greater reflects a positive screening cut-off for vestibular or oculomotor impairment. Convergence is also assessed in the VOMS using both symptom report and objective measurement of the near point of convergence (NPC, averaged across 3 trials). NPC values >5 cm reflect a positive clinical metronome, and a 1-page scoring form. The VOMS requires 5 minutes to administer and score. We will analyze VOMS at each timepoint and over time.

  12. Modified Balance Error Scoring System (mBESS) [ Time Frame: 2-week, 4-week study visits ]
    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 on a firm surface. All stances are completed with eyes closed and with hands on the iliac crests. Errors include lifting hands off the iliac crests, opening the eyes, stepping, stumbling, falling, moving the hips more than 30 degrees 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. For the current study, we will use the modified BESS (mBESS) on the firm surface only. Clinical cut-offs for BESS suggest a total error of 9 or greater indicate clinical impairment in balance. The mBESS takes approximately 5-6 minutes to administer. mBESS scores will be analyzed at each timepoint and over time.

  13. High-level Mobility Assessment Tool (HiMAT) [ Time Frame: 2-week, 4-week study visits ]
    The HiMAT will be used be used as a primary tool to assess functional balance performance in the participants. The HiMAT has 13 items including timed walking, running, skipping, and walking up and down stairs. Timed scores are transformed into ordinal scores from 0 to 4. Scores are performanced based and translated to a numerical score based on performace range. HIgh scores indicate high performance. Low scores indicate poor perforamce It was originally developed to assess mobility in individuals with TBI and tested in people with moderate to severe TBI. The HiMAT has excellent inter-rater and test-retest reliability in individuals with mTBI (greater than 0.95). A score of less than 47 discriminates between individuals with and without reported balance problems three months after mTBI. The HiMAT takes 10 minutes to administer and score. Scores will be analyzed at each timepoint and over time.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-40 years of age
  • Normal/corrected vision
  • Diagnosed with sport-related mTBI/concussion in the past 1-6 months with clear mechanism of injury
  • Glasgow coma scale (GCS) of 13 or greater
  • Reported signs of mTBI including: loss of consciousness, amnesia, disorientation, confusion, dizziness, imbalance, memory problems, vomiting
  • mTBI-related vestibular symptoms (dizziness, vertigo, motion intolerance) and/or impairments (gaze stabilization, standing balance, functional gait) per a comprehensive assessment, clinical exam, and interview

Exclusion Criteria:

  • History of vestibular disorder prior to current mTBI (benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction)
  • Benign Paroxysmal Positional Vertigo (BPPV) resulting from vestibular hypofunction
  • Dizziness symptoms that only result from exercise
  • History of neurological disorder
  • <1 month or >6 months following current mTBI
  • Currently pregnant or become pregnant during study
  • Currently involved in litigation associated with current or previous mTBI Note: history of motion sickness/sensitivity will NOT be excluded. We will adjust for any imbalance in groups on this factor by covariate analysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600324


Contacts
Contact: Anthony P Kontos, PhD 412.432.3725 akontos@pitt.edu
Contact: Valerie L Reeves, PhD 412.904.1298 vlr9@pitt.edu

Sponsors and Collaborators
University of Pittsburgh
United States Department of Defense
Investigators
Principal Investigator: Anthony P Kontos, PhD University of Pittsburgh

Responsible Party: Anthony P. Kontos, Ph.D., Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03600324     History of Changes
Other Study ID Numbers: PRO18070243
PT170144 ( Other Grant/Funding Number: Department of Defense )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers. For all study presentations and reports, aggregate data will be published.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anthony P. Kontos, Ph.D., University of Pittsburgh:
mild traumatic brain injury
vestibular impairment
vestibular rehabilitation

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Vestibular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases