Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-09-01

Brief Summary

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The goal of this study is to examine the effects of auditory beat stimulation on anxiety in patients diagnosed with bvFTD. Main aims are:

* to ascertain whether anxiety in bvFTD patients can be modulated using auditory beat stimulation
* to investigate patterns of anxiety and mind wandering in bvFTD patient population

Patients were asked to complete a number of questionnaires relating to well-being and mind wandering, as well as to listen daily to audio files of beat stimulation.

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Detailed Description

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Eligible patients and their caregivers were asked to give informed written consent, if they wished to participate after an initial interview. Once enrolled, they began the study by joining a consultation with their consultant neurologist and the study coordinator. Patients each received a handbook to guide them day by day during the course of the study and an mp3 player containing the auditory beat stimulation files. The handbook also contained copies of the questionnaires the patients were asked to complete at different points during the two week study (mind wandering questionnaire, State-Trait Anxiety Inventory, Beck Depression Inventory, Rogers' Happy/ Sad Face Scale). Over the course of two weeks patients completed the questionnaires and listened daily to an auditory beat stimulation or a control recording for 20 mins at home.

Conditions

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Anxiety bvFTD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients participated in both the control and active auditory beat conditions, each lasting 1 week. Conditions were randomised across participants.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Participants were unaware which auditory beat stimulation condition they received in which order.

Study Groups

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Monaural beat stimulation

20 min sound recording of 8Hz monaural beat

Group Type ACTIVE_COMPARATOR

Auditory beat stimulation: 8Hz monaural beat stimulation

Intervention Type OTHER

Auditory beat stimulation is a reversible, non-invasive application of sound to the ears.

Control

20 min sound recording of 220Hz pure sine wave

Group Type SHAM_COMPARATOR

Auditory beat stimulation: 8Hz monaural beat stimulation

Intervention Type OTHER

Auditory beat stimulation is a reversible, non-invasive application of sound to the ears.

Interventions

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Auditory beat stimulation: 8Hz monaural beat stimulation

Auditory beat stimulation is a reversible, non-invasive application of sound to the ears.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

A. Early disinhibition B. Early apathy or passivity C. Early loss of compassion or empathy D. speech or motor stereotypies E. Hyperorality and altered eating habits F. Neuropsychological profile with executive function deficits with relatively unchanged memory and visuospatial performance G. Disruption of daily living skills H. Matching imaging (cMRI, cCT, PET).

Eligible Sex

ALL

Accepts Healthy Volunteers

No