NCT05986279

Brief Summary

The purpose of this study is twofold: 1) Develop norms for measures of inner ear function and psychological health, and 2) Examine the feasibility of using the MINDGAPS system (a remote monitoring system) to track progress during physical therapy or rehabilitation for inner ear problems following a concussion or mild Traumatic Brain Injury.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Aug 2023Sep 2027

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2027

Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

4.1 years

First QC Date

August 3, 2023

Last Update Submit

December 3, 2024

Conditions

Vestibular Hypofunction

Keywords

Rehabilitationmild traumatic brain injurydynamic visual acuitygaze stabilitypostural stabilitydizzinesspsychological health

Outcome Measures

Primary Outcomes (1)

  • Computerized Dynamic Visual Acuity (cDVA)

    computerized measure of functional gaze stability

    through study completion, an average of 12 weeks

Secondary Outcomes (14)

  • Instrumented postural sway assessment

    through study completion, an average of 12 weeks

  • Video head impulse testing (vHIT)

    through study completion, an average of 12 weeks

  • Functional Gait Assessment (FGA)

    through study completion, an average of 12 weeks

  • Dizziness Handicap Inventory (DHI)

    through study completion, an average of 12 weeks

  • Life Space Mobility Assessment (LSA)

    through study completion, an average of 12 weeks

  • +9 more secondary outcomes

Study Arms (2)

Rehab

EXPERIMENTAL

6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system

Other: Rehab

Observational

NO INTERVENTION

Normative data development of performance on vestibular measures following mTBI

Interventions

RehabOTHER

6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system

Rehab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran or Active Duty Military Service Member
  • Ability to stand independently
  • Legally autonomous and able to self-consent

You may not qualify if:

  • Acute head injury (within the previous 2 months)
  • History of moderate or severe head injury (i.e., loss of consciousness greater than 30 minutes or post-traumatic amnesia greater than 1 day)
  • Current diagnosis of spine disorders in the neck
  • Diagnosis of problems with the arteries in your neck
  • Blindness
  • If you have been diagnosed with abnormal eye movements (also called "ocular motor palsy")
  • If you have previously had a stroke or been diagnosed with a neurodegenerative disorder ( e.g., Parkinson's Disease, Multiple Sclerosis)
  • If you have been previously diagnosed primary vestibular dysfunction ( e.g., congenital peripheral vestibular syndrome)
  • If you have previously been diagnosed with a brain tumor
  • If you are currently receiving physical therapy care for balance or dizziness problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

University of Montana

Missoula, Montana, 59812, United States

RECRUITING

MeSH Terms

Conditions

Brain ConcussionDizzinessPsychological Well-Being

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Brian Loyd, PhD

CONTACT

406-243-4015Brian.loyd@umontana.edu

Andy Kittelson, PhD

CONTACT

406-243-4015Andy.kittelson@umontana.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group is enrolled into a longitudinal, single group intervention using vestibular rehab. The other group is enrolled as a cross-sectional observational assessment used for developing normative data.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

August 30, 2023

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

September 29, 2027

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

US(2)