Vestibular Therapy for Alzheimer's Disease

Overseen By Yuri Agrawal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Antihistamines, Benzodiazepines

Disqualifiers: Severe AD, Non-AD dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether vestibular therapy can reduce the risk of falls in people with Alzheimer's disease. Vestibular therapy involves exercises that improve balance by targeting the inner ear, which maintains stability. Participants will either receive vestibular therapy or join an active control group, which includes eye and conditioning exercises that do not directly affect balance. The study seeks participants with mild to moderate Alzheimer's who experience balance issues and have a caregiver to assist with the process. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance balance therapies for Alzheimer's patients.

Will I have to stop taking my current medications?

If you are taking daily vestibular suppressant medications like anti-histamines or benzodiazepines, you will need to stop them to participate in the trial.

What prior data suggests that vestibular therapy is safe for Alzheimer's patients?

Studies have shown that vestibular therapy (VT) can reduce the risk of falls by about 20-40% in both younger and older adults. This therapy improves balance and stability by targeting the inner ear, which is crucial for maintaining balance. VT is generally well-tolerated, with no significant reports of serious side effects. However, while researchers have studied VT in other groups, its effects on people with Alzheimer's disease remain unexplored. Thus, although VT appears safe overall, its use for Alzheimer's patients represents a new area of research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vestibular therapy for Alzheimer's disease because it offers a fresh approach by targeting vestibular function, which is usually not addressed in standard Alzheimer's treatments. Unlike typical therapies that focus on slowing cognitive decline through medication, vestibular therapy involves physical exercises designed to improve balance and spatial orientation. By enhancing vestibular function, this therapy could potentially improve patients' overall quality of life and independence, offering benefits beyond what current medications provide. Additionally, this method is non-invasive and administered by a physical therapist, making it an accessible option for many patients.

What evidence suggests that vestibular therapy is effective for improving balance in Alzheimer's patients?

Research has shown that vestibular therapy (VT) can lower the risk of falls by about 20-40% in both younger and older adults. VT is known to improve balance in healthy older adults. However, its effects on people with Alzheimer's disease (AD) have not been directly studied. This trial will provide VT to some participants to assess its potential benefits for individuals with AD, who often struggle with balance and movement. Others will join an active control group, engaging in exercises that do not specifically challenge the vestibular system. In people with normal cognitive abilities, VT has improved balance and reduced symptoms related to inner ear issues. Researchers hope similar benefits will apply to individuals with AD. ^{1 2 3 5 6}

Who Is on the Research Team?

Yuri Agrawal, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people over 60 with mild-to-moderate Alzheimer's who have balance issues due to inner ear problems. They need a caregiver available and must be able to do certain tests and therapy sessions. Those with severe Alzheimer's, other dementias, or conditions that limit participation (like needing a cane) can't join.

Inclusion Criteria

You have problems with balance and dizziness due to issues with your inner ear.

I have been diagnosed with mild to moderate Alzheimer's disease.

I have a caregiver who can spend at least 10 hours a week with me and participate in study procedures.

Exclusion Criteria

I am not taking daily medications for dizziness, like anti-histamines or benzodiazepines.

I cannot commit to 8 weeks of the treatment or control program.

I am unable to take part in the study due to health issues or need for mobility aids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week course of vestibular therapy or active control exercises

8 weeks

Follow-up

Participants are monitored for incidence of falls over a 1-year period

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Active control
• Vestibular physical therapy

Trial Overview

The study is testing if vestibular therapy, which helps improve balance by focusing on the inner ear system, can reduce falls in Alzheimer's patients. Participants will either receive this special therapy or an active control treatment in a randomized setup.

How Is the Trial Designed?

Group I: Vestibular therapy Experimental Treatment 1 Intervention

Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function.

Group II: Active control Active Control 1 Intervention

The active control regimen consists of eye movement exercises (e.g. smooth pursuit eye movements) and also general conditioning exercises (e.g. range of motion exercises, lifting light weights with the arms and legs). This regimen is "vestibular neutral" in that head movements which specifically challenge the vestibular system are avoided.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Individuals with Alzheimer's disease (AD) have a higher prevalence of vestibular impairment, which increases their risk of falls, making it a significant health concern for them and their caregivers.

The article proposes a modified vestibular physical therapy (VPT) protocol tailored for individuals with cognitive impairment, focusing on their motor learning abilities and the importance of building a strong therapeutic relationship, with ongoing research assessing its effectiveness in improving balance and reducing falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Physical Therapy in Individuals With Cognitive Impairment: A Theoretical Framework. Klatt, BN., Ries, JD., Dunlap, PM., et al.[2020]

This pilot clinical trial aims to evaluate the feasibility of vestibular therapy (VT) in reducing falls and improving balance in 100 patients with mild to moderate Alzheimer's disease who have vestibular loss, with assessments conducted at baseline, 8 weeks, and 1 year.

Falls are a major concern for Alzheimer's patients, and this study seeks to address the high risk of falls by implementing VT, which has been shown to improve balance and reduce fall risk, potentially benefiting a growing population of AD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. Yesantharao, LV., Rosenberg, P., Oh, E., et al.[2022]

Vestibular rehabilitation therapy (VRT) significantly improved dizziness in elderly patients with chronic vestibular dysfunction, as shown by a notable decrease in dizziness handicap inventory (DHI) scores after 8 weeks of therapy.

In a study of 33 patients over 60 years old, VRT exercises led to marked improvements in balance and function, particularly in those with abnormal canal paralysis, indicating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. Bayat, A., Pourbakht, A., Saki, N., et al.[2022]

In a study of 801 patients with Alzheimer disease, only 6.0% were referred to physical therapy (PT) and a mere 0.6% to vestibular physical therapy (VPT), indicating a significant underutilization of these beneficial interventions.

Despite the known benefits of PT and VPT in improving balance and reducing fall risk in individuals with Alzheimer disease, the low referral rates suggest a gap in care that could impact patient safety and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and Vestibular Physical Therapy Referrals in People With Alzheimer Disease. Gandhi, P., Klatt, BN., Agrawal, Y.[2023]

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]

A pilot study involving 22 participants with mild cognitive impairment showed that a novel sensor-based balance training program significantly reduced postural sway and fear of falling after 4 weeks of training, indicating its potential efficacy in improving balance.

The majority of participants (92%) found the training enjoyable and felt that the real-time feedback from wearable sensors was helpful, suggesting a positive user experience that supports the feasibility of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-based balance training with motion feedback in people with mild cognitive impairment. Schwenk, M., Sabbagh, M., Lin, I., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6465065/

Vestibular physical therapy in individuals with cognitive ...

However, the effectiveness of VPT in improving balance and reducing falls in individuals with AD who have vestibular loss has never been explored.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03799991

NCT03799991 | Vestibular Therapy in Alzheimer's Disease

Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function ...

3.

pilotfeasibilitystudies.biomedcentral.com

pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-01133-w

Vestibular therapy to reduce falls in people with Alzheimer's ...

In fact, a number of studies have shown that VT reduces the rate of falls ~20-40% [37,38,39,40,41], in both younger and older adults [42,43,44].

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7704935/

Physical and Vestibular Physical Therapy Referrals in ...

A substantial body of evidence supports the effectiveness of VPT in improving balance and reducing symptoms in individuals with intact cognition with vestibular ...

5.

jgerontology-geriatrics.com

jgerontology-geriatrics.com/article/view/762

Effect of vestibular therapy as an adjunct to cognitive ...

Effect of vestibular therapy as an adjunct to cognitive therapy to improve cognition in elderly with mild cognitive impairment (MCI): A Randomized Controlled ...

6.

neuropt.org

neuropt.org/docs/default-source/vestibular-sig/vsig-newsletters/update-1-8-24_tvpt-winter-jan-2025.pdf?sfvrsn=765943_1

topics in vestibular physical therapy

Introduction: This article examines the relationship between vestibular function and cognitive impairment, with a particular focus on Alzheimer.