Vestibular Therapy in Alzheimer's Disease

• ClinicalTrials.gov Identifier: NCT03799991
• Recruitment Status: Recruiting
• First Posted: January 10, 2019
• Last Update Posted: December 14, 2022
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Yuri Agrawal, MD; 4105023107; yagrawa1@jhmi.edu

Locations

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

Investigators

• Principal Investigator: Yuri Agrawal, MD; Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03799991
• Other Study ID Numbers: IRB00273752
• First Posted: January 10, 2019
• Last Update Posted: December 14, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vestibular Diseases; Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases