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Vestibular Therapy in Alzheimer's Disease

Primary Purpose

Vestibular Diseases, Vestibular Disorder, Alzheimer Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vestibular physical therapy

Active control

About this trial

This is an interventional treatment trial for Vestibular Diseases

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vestibular therapy

Active control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of participant falls

Incidence of falls over a 1-year follow-up period

Secondary Outcome Measures

Full Information

NCT ID

NCT03799991

First Posted

January 8, 2019

Last Updated

December 13, 2022

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT03799991

Brief Title

Vestibular Therapy in Alzheimer's Disease

Official Title

Vestibular Therapy in Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibular Diseases, Vestibular Disorder, Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vestibular therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Active control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Vestibular physical therapy

Intervention Description

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

Intervention Name(s)

Active control

Intervention Description

Strength and flexibility exercises that do not involve head movements.

Primary Outcome Measure Information:

Title

Number of participant falls

Description

Incidence of falls over a 1-year follow-up period

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuri Agrawal, MD

Phone

4105023107

yagrawa1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuri Agrawal, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuri Agrawal

First Name & Middle Initial & Last Name & Degree

John Carey, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35918757

Citation

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.

Results Reference

derived

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Vestibular Therapy in Alzheimer's Disease

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