Vestibular Therapy in Alzheimer's Disease

NCT ID: NCT03799991

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2027-08-26

Brief Summary

Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.

Conditions

Vestibular Diseases; Vestibular Disorder; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vestibular therapy

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

Group Type: EXPERIMENTAL

Vestibular physical therapy

Intervention Type: BEHAVIORAL

Vestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks.

Active control

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.

Group Type: ACTIVE_COMPARATOR

Active control

Intervention Type: BEHAVIORAL

Strength and flexibility exercises that do not involve head movements.

Interventions

Vestibular physical therapy

Vestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks.

Intervention Type: BEHAVIORAL

Active control

Strength and flexibility exercises that do not involve head movements.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2).
• Age ≥ 60 years.
• Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses).
• Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control.
• Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control.
• Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy.

Exclusion Criteria

• Diagnosis of severe AD (CDR≥3).
• Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia.
• Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.)
• Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT.
• Lack of availability to participate in 8 weeks of VT or active control.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuri Agrawal, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yuri Agrawal, MD

Role: CONTACT

yagrawa1@jhmi.edu

4105023107

Facility Contacts

Yuri Agrawal

Role: primary

References

Yesantharao LV, Rosenberg P, Oh E, Leoutsakos J, Munro CA, Agrawal Y. Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Aug 2;8(1):167. doi: 10.1186/s40814-022-01133-w.

Reference Type: DERIVED

PMID: 35918757 (View on PubMed)

Other Identifiers

R01AG065259

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00273752

Identifier Type: -

Identifier Source: org_study_id