IVE Therapy vs Traditional Rehabilitation for Concussion

(INVENT Trial)

No longer recruiting at 2 trial locations

Overseen By Jennifer Millar, MSPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Ophthalmic, Neuromuscular, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks per treatment phase with a 6-week washout period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether traditional vestibular rehab exercises or a new device called Incremental Velocity Error (IVE) is more effective for treating dizziness and balance issues. The IVE device, worn on the head, helps improve eye and head coordination. Participants will try both treatments to identify which works best. The trial seeks active duty service members with mild traumatic brain injury (mTBI) and civilians experiencing dizziness or imbalance due to vestibular issues. As an unphased trial, it offers participants the opportunity to explore innovative treatments for vestibular issues.

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 prior data suggests that the Incremental Velocity Error (IVE) device is safe for improving vestibular rehabilitation?

Research has shown that traditional vestibular rehabilitation therapy (VPT) is generally safe for individuals who have experienced a concussion. Initiating this therapy soon after a concussion does not appear to hinder recovery. One study found that conducting VPT in a group setting was both safe and effective for addressing dizziness and balance issues following a brain injury.

For the Incremental Velocity Error (IVE) treatment, specific safety data is not yet available. The trial is in an early phase called "Not Applicable," indicating limited safety data, though the treatment is not expected to pose major safety concerns. In these early trials, new treatments are typically tested to ensure safety before more detailed studies are conducted.

Both treatments, VPT and IVE, appear to be well-tolerated based on current knowledge. However, individuals considering joining a trial should consult their doctor about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Incremental Velocity Error (IVE) therapy for concussion recovery because it introduces a new method of engaging the vestibular system. Unlike traditional vestibular rehabilitation, which uses standard eye and head-turning exercises, IVE employs a device worn on the head that presents a moving target during head motion, potentially enhancing brain engagement and recovery. This innovative approach could offer a more dynamic and interactive way to improve balance and gait, setting it apart from conventional methods.

What evidence suggests that this trial's treatments could be effective for concussion?

Research has shown that traditional vestibular rehabilitation therapy (VPT), one of the treatments in this trial, effectively reduces dizziness and improves balance in people with concussions. It alleviates symptoms such as spinning sensations and unsteadiness. In contrast, the Incremental Velocity Error (IVE) device, another treatment option in this trial, is a newer method designed to improve the vestibulo-ocular reflex, which stabilizes vision during head movement. Early research suggests that this device might enhance physical performance, crucial for maintaining balance and clear vision. While both treatments offer benefits, the trial continues to study the IVE device to confirm its effectiveness compared to traditional methods. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael C Schubert, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Incremental Velocity Error (IVE)
• Traditional Vestibular Rehabilitation (VPT)

Trial Overview

The 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.

How Is the Trial Designed?

Group I: IVE/VPT 3 week Crossover Experimental Treatment 2 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 Crossover Active Control 2 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 crossover Active Control 2 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.

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+

Published Research Related to This Trial

Vestibular physical therapy (VPT) is an evidence-based treatment aimed at reducing symptoms like vertigo, dizziness, and imbalance, which can significantly improve patients' quality of life.

The therapy emphasizes patient safety and includes fall risk assessments to prevent falls, making it a comprehensive approach to managing vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Physical Therapy and Fall Risk Assessment. Carender, WJ., Grzesiak, M., Telian, SA.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Vestibular rehabilitation (VR) is a safe and effective physical therapy for managing peripheral vestibular dysfunction, with moderate to strong evidence supporting its efficacy.

VR promotes recovery in central vestibular dysfunction by using specific exercises that activate neuroplastic mechanisms, allowing the central nervous system to adapt and compensate for impaired functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central vestibular dysfunction: don't forget vestibular rehabilitation. Zhang, S., Liu, D., Tian, E., et al.[2022]

In a study of 69 patients with chronic unilateral vestibular hypofunction, vestibular rehabilitation therapy combined with Wii® therapy significantly reduced dizziness handicap, as shown by a decrease in the Dizziness Handicap Inventory score from a median of 40 to 24 (P<.0001).

The therapy also improved balance and visual stability, with the Dynamic Gait Index score increasing from a median of 21 to 23 and dynamic visual acuity improving from a median of 2 to 1, both with statistical significance (P<.0001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. Verdecchia, DH., Mendoza, M., Sanguineti, F., et al.[2022]

The visio-vestibular examination (VVE) shows fair to moderate inter-rater reliability among different providers and moderate to substantial test-retest reliability among the same provider in a pediatric emergency department, indicating it can be a reliable tool for assessing concussion in children aged 6-18 years.

The VVE's ability to evaluate specific deficits related to concussion can aid in early diagnosis and risk stratification, which is crucial for improving outcomes in concussed youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of the visio-vestibular examination for concussion among providers in a pediatric emergency department. Corwin, DJ., Arbogast, KB., Swann, C., et al.[2021]

The incremental VOR adaptation (IVA) training method significantly improved the vestibulo-ocular reflex (VOR) gain in a 51-year-old male with bilateral vestibular hypofunction, showing improvements of 179% to 600% over 645 days of use.

In addition to enhancing VOR gain, the IVA method also led to improvements in standing posture and gait, indicating its potential effectiveness in rehabilitating individuals with severe vestibular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VOR adaptation training and retention in a patient with profound bilateral vestibular hypofunction. Gimmon, Y., Migliaccio, AA., Kim, KJ., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the dizzy patient. Tee, LH., Chee, NW.[2022]

In a study involving 47 participants with peripheral vestibular disorders, both those with only semicircular canal dysfunction and those with additional otolith dysfunction showed significant improvements after an 8-week vestibular rehabilitation program.

The presence of otolith dysfunction did not significantly affect the outcomes of rehabilitation, indicating that vestibular rehabilitation is effective for improving symptoms and balance regardless of otolith involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does otolith organ dysfunction influence outcomes after a customized program of vestibular rehabilitation? Murray, KJ., Hill, K., Phillips, B., et al.[2022]

The novel adaptive vestibular rehabilitation (AVR) program showed a clinically and statistically significant improvement in symptoms for patients with unilateral vestibular hypofunction, reducing their Dizziness Handicap Inventory (DHI) scores from an average of 42 to 11.5 after just 4 weeks of therapy.

This AVR method offers advantages over traditional vestibular rehabilitation by being more cost-effective and customizable to individual patient needs, demonstrating its potential for better patient adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adaptive vestibular rehabilitation technique. Crane, BT., Schubert, MC.[2019]

Vestibular Rehabilitation Therapy (VRT) utilizes specific head, eye, and body movements to stimulate the body's natural adaptive mechanisms for rehabilitating vertigo patients.

The anti-vertigo drug Betahistine can enhance the compensation process in patients undergoing VRT, making it a suitable adjunct treatment for improving rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rote of adaptation exercises in clinical practice. Kirtane, MV.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8666079/

study protocol for a randomized controlled crossover trial

Within the population of US military service members exposed to mild traumatic brain injury (mTBI), 15–44% will develop multi-sensory impairment following a ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03846830

Incremental Velocity Error as a New Treatment in ...

The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device ...

3.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05876-4

Incremental Velocity Error as a New Treatment in Vestibular ...

Within the population of US military service members exposed to mild traumatic brain injury (mTBI), 15–44% will develop multi-sensory impairment ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34895314/

study protocol for a randomized controlled crossover trial

The aim of the Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) trial is to assess the efficacy of a non-invasive, ...

5.

withpower.com

withpower.com/trial/phase-brain-injuries-9-2021-7c92e

IVE Therapy vs Traditional Rehabilitation for Concussion · ...

Studies indicate that early vestibular rehabilitation can help improve vertigo and unsteadiness in patients with head injuries, suggesting potential benefits ...

6.

researchgate.net

researchgate.net/publication/352896447_Incremental_Velocity_Error_As_A_New_Treatment_In_Vestibular_Rehabilitation_INVENT_VPT_Trial_Study_Protocol_For_A_Randomized_Controlled_Crossover_Trial

(PDF) Incremental Velocity Error As A New Treatment In ...

Within the population of US military service members exposed to mild traumatic brain injury (mTBI), 15–44% will develop multi-sensory impairment following a ...

7.

jhu.pure.elsevier.com

jhu.pure.elsevier.com/en/publications/incremental-velocity-error-as-a-new-treatment-in-vestibular-rehab

Incremental Velocity Error as a New Treatment in Vestibular ...

The aim of the Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) trial is to assess the efficacy of a non-invasive, ...