Clinical trial NCT03600324: Randomized Controlled Trial for Vestibular Treatment in Concussion
Official title: Randomized Controlled Trial for Vestibular Treatment in Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Mild Traumatic Brain Injury
Keywords: mild traumatic brain injury
vestibular impairment
vestibular rehabilitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-07-26
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A prospective, single-blind, four-group multi-center randomized controlled trial
Primary purpose: TREATMENT

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 18-50 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.

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.

Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Normal/corrected vision
* Diagnosed with sport-related mTBI/concussion in the past 8 days-1 year 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

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: enrollment, 2-week, 4-week, 3-month study visits
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: enrollment, 2-week, 4-week, 3-month study visits
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: enrollment, 2-week, 4-week, 3-month study visits
measure: Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)
timeFrame: enrollment, 2-week, 4-week study visits
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: enrollment, 2-week, 4-week study visits
measure: Identify (ID) Migraine
timeFrame: enrollment, 2-week, 4-week study visits
measure: Neck Pain Numerical Rating Scale (Neck Pain NRS)
timeFrame: enrollment, 2-wk, 4-wk study visits
measure: Dizziness Numerical Rating Scale (Dizziness NRS)
timeFrame: enrollment, 2-wk, 4-wk study visits
measure: Behavioral Symptom Inventory-18 (BSI-18)
timeFrame: enrollment, 2-week, 4-week study visits
measure: Return to Activity (RTA)
timeFrame: 4-week, 3-month study visits
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: enrollment, 2-week, 4-week study visits
measure: Visual Vertigo Analog Scale (VVAS)
timeFrame: 2-week, 4-week study visits
measure: Vestibular Ocular Motor Screening (VOMS)
timeFrame: 2-wk, 4-wk study visits
measure: Modified Balance Error Scoring System (mBESS)
timeFrame: 2-week, 4-week study visits
measure: Functional Gait Assessment (FGA)
timeFrame: enrollment, 2-week, 4-week study visits
measure: High Level Mobility Assessment Tool (HiMAT)
timeFrame: enrollment, 2-week, 4-week study visits
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Warrior Recovery Center
state: Colorado
city: Camp Lejeune
country: United States
facility: Naval Medical Center Camp Lejeune - Intrepid Spirit Concussion Recovery Center
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC/Univ of Pgh Sports Medicine Concussion Research Program
state: Pennsylvania
city: Fort Hood
country: United States
facility: Carl R. Darnall Army Medical Center - Intrepid Spirit Center
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Anthony P Kontos, PhD
role: PRINCIPAL_INVESTIGATOR
References: