24 Participants Needed

IVE Therapy vs Traditional Rehabilitation for Concussion

(INVENT Trial)

Recruiting at 2 trial locations
JM
Overseen ByJennifer Millar, MSPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

MC

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

I have had a mild traumatic brain injury or vestibular hypofunction and experience dizziness or imbalance.

Exclusion Criteria

I am 18 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo vestibular rehabilitation using either the Incremental Velocity Error (IVE) device or traditional Vestibular Rehabilitation (VPT) with a crossover design.

5 weeks per treatment phase with a 6-week washout period
Daily exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for long-term outcomes and effectiveness

Up to 6 months

Treatment Details

Interventions

  • Incremental Velocity Error (IVE)
  • Traditional Vestibular Rehabilitation (VPT)
Trial OverviewThe study compares traditional Vestibular Rehabilitation Therapy (VPT) to a new device called Incremental Velocity Error (IVE), which aims to enhance the performance of the vestibulo-ocular reflex that helps with balance and eye movements.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: IVE/VPT 3 week CrossoverExperimental Treatment2 Interventions
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period.
Group II: IVE/VPT 6 week CrossoverActive Control2 Interventions
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training.
Group III: IVE/VPT 3 week crossoverActive Control2 Interventions
Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Fort Belvoir Community Hospital

Collaborator

Trials
15
Recruited
2,100+

Neuroscience Research Australia

Collaborator

Trials
14
Recruited
1,800+

Walter Reed National Military Medical Center

Collaborator

Trials
149
Recruited
33,800+

Findings from Research

The INVENT VPT trial aims to evaluate the effectiveness of a new non-invasive vestibular adaptation training device in improving the vestibulo-ocular reflex in military service members with mild traumatic brain injury and civilians with vestibular hypofunction, addressing a significant gap in evidence-based vestibular rehabilitation practices.
This multi-center randomized controlled crossover trial will compare traditional vestibular rehabilitation methods with the new device, potentially leading to optimized treatment strategies and better outcomes for patients suffering from multi-sensory impairment.
Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial.Ervin, AM., Schubert, MC., Migliaccio, AA., et al.[2022]
A study involving 20 head trauma patients demonstrated that those who received vestibular rehabilitation alongside medication (Betaserc) showed significantly greater improvement in managing vertigo and unsteadiness compared to those who only received medication after one month (P=0.000).
The findings suggest that early vestibular rehabilitation can enhance recovery and stability in head trauma patients, indicating that combining rehabilitation exercises with medical treatment leads to faster and more effective outcomes.
Effect of Early Vestibular Rehabilitation on Vertigo and Unsteadiness in Patients with Acute and Sub-Acute Head Trauma.Jafarzadeh, S., Pourbakht, A., Bahrami, E., et al.[2022]
Customized vestibular rehabilitation therapy (VRT) is an effective treatment for patients experiencing symptoms like vertigo, gaze instability, and balance issues due to vestibular dysfunction.
The paper outlines specific patient selection criteria and rehabilitation strategies for both unilateral and bilateral vestibular deficits, highlighting the strong evidence supporting VRT's efficacy in improving patient outcomes.
Vestibular rehabilitation therapy for the dizzy patient.Tee, LH., Chee, NW.[2022]

References

Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial. [2022]
Effect of Early Vestibular Rehabilitation on Vertigo and Unsteadiness in Patients with Acute and Sub-Acute Head Trauma. [2022]
Vestibular rehabilitation therapy for the dizzy patient. [2022]
Does otolith organ dysfunction influence outcomes after a customized program of vestibular rehabilitation? [2022]
An adaptive vestibular rehabilitation technique. [2019]
Central vestibular dysfunction: don't forget vestibular rehabilitation. [2022]
Reliability of the visio-vestibular examination for concussion among providers in a pediatric emergency department. [2021]
Vestibular Physical Therapy and Fall Risk Assessment. [2021]
VOR adaptation training and retention in a patient with profound bilateral vestibular hypofunction. [2020]
Rote of adaptation exercises in clinical practice. [2021]
Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. [2022]