We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Vestibular Therapy in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03799991
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : December 14, 2022
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Vestibular Diseases Vestibular Disorder Alzheimer Disease Behavioral: Vestibular physical therapy Behavioral: Active control Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vestibular Therapy in Alzheimer's Disease
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vestibular therapy
Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function.
Behavioral: 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.

Active Comparator: 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.
Behavioral: Active control
Strength and flexibility exercises that do not involve head movements.

Primary Outcome Measures :
  1. Number of participant falls [ Time Frame: 1 year ]
    Incidence of falls over a 1-year follow-up period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799991

Layout table for location contacts
Contact: Yuri Agrawal, MD 4105023107 yagrawa1@jhmi.edu

Layout table for location information
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Yuri Agrawal         
Principal Investigator: John Carey, MD         
Sponsors and Collaborators
Johns Hopkins University
Layout table for investigator information
Principal Investigator: Yuri Agrawal, MD Johns Hopkins University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03799991    
Other Study ID Numbers: IRB00273752
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vestibular Diseases
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases