IVE Therapy vs Traditional Rehabilitation for Concussion
(INVENT Trial)
Trial Summary
What is the purpose of this trial?
The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of Incremental Velocity Error (IVE) therapy for concussion treatment?
Research shows that vestibular rehabilitation, which includes treatments like Incremental Velocity Error (IVE) therapy, is effective for managing symptoms like dizziness and balance issues in patients with vestibular dysfunction, including those with head trauma. Studies indicate that early vestibular rehabilitation can help improve vertigo and unsteadiness in patients with head injuries, suggesting potential benefits for concussion recovery.12345
Is Incremental Velocity Error (IVE) therapy safe for humans?
There is moderate to strong evidence that vestibular rehabilitation, which includes Incremental Velocity Error (IVE) therapy, is safe for managing peripheral vestibular dysfunction. Safety and fall prevention are important aspects of vestibular physical therapy, which is designed to address symptoms like dizziness and imbalance.16789
How is Incremental Velocity Error (IVE) therapy different from traditional treatments for concussion?
Incremental Velocity Error (IVE) therapy is unique because it focuses on gaze stability training, which is a key component of vestibular rehabilitation, using a non-invasive device to help normalize the vestibulo-ocular reflex (the reflex that stabilizes vision during head movements). This approach is different from traditional vestibular rehabilitation, which typically involves exercises without such a device.1251011
Research Team
Michael C Schubert, PhD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for active duty service members with mild traumatic brain injury (mTBI) and civilians who have vestibular hypofunction, experiencing symptoms like dizziness or imbalance. Participants must be at least 18 years old.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo vestibular rehabilitation using either the Incremental Velocity Error (IVE) device or traditional Vestibular Rehabilitation (VPT) with a crossover design.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to be monitored for long-term outcomes and effectiveness
Treatment Details
Interventions
- Incremental Velocity Error (IVE)
- Traditional Vestibular Rehabilitation (VPT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Fort Belvoir Community Hospital
Collaborator
Neuroscience Research Australia
Collaborator
Walter Reed National Military Medical Center
Collaborator