Randomized Controlled Trial for Vestibular Treatment in Concussion

NCT03600324 | Completed DMC

• 2 other identifiers: PRO18070243PT170144
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 4

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.

Conditions

Vestibular Disorder; Mild Traumatic Brain Injury

Keywords

mild traumatic brain injury; vestibular impairment; vestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

• Dizziness Handicap Inventory (DHI)

  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.

  enrollment, 2-week, 4-week, 3-month study visits

Secondary Outcomes (15)

• Patient Global Impression of Change (PGIC)

  enrollment, 2-week, 4-week, 3-month study visits

• Neurobehavioral Symptom Inventory (NSI)

  enrollment, 2-week, 4-week, 3-month study visits

• Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)

  enrollment, 2-week, 4-week study visits

• Pittsburgh Sleep Quality Index (PSQI)

  enrollment, 2-week, 4-week study visits

• Identify (ID) Migraine

  enrollment, 2-week, 4-week study visits

Study Arms (4)

Low Intensity/Low Frequency

EXPERIMENTAL

Participants will be assigned T-REV with low intensity (30% of perceived effort) and low frequency (exercises performed 1x/day)

Behavioral: T-REV

Low Intensity/ High Frequency

EXPERIMENTAL

Participants will be assigned T-REV with low intensity (30% of perceived effort) and high frequency (exercises performed 2x/day)

Behavioral: T-REV

High Intensity/Low Frequency

EXPERIMENTAL

Participants will be assigned T-REV with high intensity (70% of perceived effort) and low frequency (exercises performed 1x/day)

Behavioral: T-REV

High Intensity/High Frequency

EXPERIMENTAL

Participants will be assigned T-REV with high intensity (70% of perceived effort) and high frequency (exercises performed 2x/day)

Behavioral: T-REV

Interventions

T-REV BEHAVIORAL

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.

High Intensity/High Frequency; High Intensity/Low Frequency; Low Intensity/ High Frequency; Low Intensity/Low Frequency

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Department of Defense: collaborator

Study Sites (4)

Warrior Recovery Center

Colorado Springs, Colorado, 80913, United States

Location

Naval Medical Center Camp Lejeune - Intrepid Spirit Concussion Recovery Center

Marine Corps Base Camp Lejeune, North Carolina, 28547, United States

Location

UPMC/Univ of Pgh Sports Medicine Concussion Research Program

Pittsburgh, Pennsylvania, 15203, United States

Location

Carl R. Darnall Army Medical Center - Intrepid Spirit Center

Fort Hood, Texas, 76544, United States

Location

MeSH Terms

Conditions

Vestibular Diseases; Brain Concussion

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Anthony P Kontos, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A prospective, single-blind, four-group multi-center randomized controlled trial

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: February 26, 2020
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)