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Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

Primary Purpose

Anxiety, bvFTD

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Auditory beat stimulation: 8Hz monaural beat stimulation
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety

Eligibility Criteria

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

Inclusion Criteria: Inclusion criteria are the international criteria of a behavioral variant of FTD according to Raskovsky and colleagues (2011), which include: 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). Exclusion Criteria: Exclusion criteria include the presence of a non-neurodegenerative psychiatric disease that can better explain the behavioral abnormalities or evidence of biomarkers with clear evidence of Alzheimer's disease or other neurodegenerative process

Sites / Locations

  • Juergen Fell

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Monaural beat stimulation

Control

Arm Description

20 min sound recording of 8Hz monaural beat

20 min sound recording of 220Hz pure sine wave

Outcomes

Primary Outcome Measures

Examine anxiety modulation effects of monaural beat stimulation using the State-Trait Anxiety Inventory (STAI-S and T)
The STAI Inventory was used to assess the patients' state (STAI-S) and trait (STAI-T) anxiety. The two subscores differentiate between transient feelings of anxiety (state anxiety), i.e. those related to a particular context like an event, and anxiety levels that are more of a personal characteristic of an individual (trait anxiety: Spielberger et al., 1983). Patients responded to 20 statements contained in each subscore, using a 4-point Likert scale (not at all: 1; a little: 2; quite: 3; very: 4). The STAI Inventory was completed at the beginning and end of each week.
Examine depression modulation effects of monaural beat stimulation using the Beck Depression Inventory
metric used to assess levels of depression; The BDI is a 21-item multiple-choice questionnaire (Beck et al., 1996). The BDI was used to assess symptoms of depression, and was administered at the beginning and end of each week, prior to the six-day daily course of auditory beat stimulation. The BDI is categorised into the following scoring ranges: 0-13 minimal; 14-19 mild; 20-28 moderate and 29-63 severe.
Examine mind wandering modulation effects of monaural beat stimulation using the Mind Wandering Questionnaire
The Mind Wandering Questionnaire is a short-form scale intended to measure the propensity to mind wander (Mrazek et al., 2013). The questionnaire consists of five items that evaluate trait levels of mind wandering. Trait mind wandering is scored across a 6-point Likert scale (1: almost never; 2: very infrequently; 3: somewhat infrequently; 4: somewhat frequently; 5: very frequently; 6: almost always). Patients completed this questionnaire, also at the beginning and end of each week.
Examine daily momentary subjective levels of anxiety, mood and pain modulation effects of monaural beat stimulation using the Mind Wandering Questionnaire
The Rogers' Happy/ Sad Face Scale is a visual-numeric scale that was intended to capture the momentary subjective levels of anxiety, mood and pain. Patients had to grade their feelings according to a corresponding face icon which represented a 'happy face' at the most positive end (value of 0) of the graded scale, all the way to a 'crying face' icon at the most negative end of the scale (value of 4). Patients completed this scale twice daily, once immediately prior to the auditory stimulation, and then immediately after the stimulation had concluded.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2023
Last Updated
June 14, 2023
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT05917886
Brief Title
Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia
Official Title
Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients participated in both the control and active auditory beat conditions, each lasting 1 week. Conditions were randomised across participants.
Masking
ParticipantCare Provider
Masking Description
Participants were unaware which auditory beat stimulation condition they received in which order.
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monaural beat stimulation
Arm Type
Active Comparator
Arm Description
20 min sound recording of 8Hz monaural beat
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
20 min sound recording of 220Hz pure sine wave
Intervention Type
Other
Intervention Name(s)
Auditory beat stimulation: 8Hz monaural beat stimulation
Intervention Description
Auditory beat stimulation is a reversible, non-invasive application of sound to the ears.
Primary Outcome Measure Information:
Title
Examine anxiety modulation effects of monaural beat stimulation using the State-Trait Anxiety Inventory (STAI-S and T)
Description
The STAI Inventory was used to assess the patients' state (STAI-S) and trait (STAI-T) anxiety. The two subscores differentiate between transient feelings of anxiety (state anxiety), i.e. those related to a particular context like an event, and anxiety levels that are more of a personal characteristic of an individual (trait anxiety: Spielberger et al., 1983). Patients responded to 20 statements contained in each subscore, using a 4-point Likert scale (not at all: 1; a little: 2; quite: 3; very: 4). The STAI Inventory was completed at the beginning and end of each week.
Time Frame
3 years
Title
Examine depression modulation effects of monaural beat stimulation using the Beck Depression Inventory
Description
metric used to assess levels of depression; The BDI is a 21-item multiple-choice questionnaire (Beck et al., 1996). The BDI was used to assess symptoms of depression, and was administered at the beginning and end of each week, prior to the six-day daily course of auditory beat stimulation. The BDI is categorised into the following scoring ranges: 0-13 minimal; 14-19 mild; 20-28 moderate and 29-63 severe.
Time Frame
3 years
Title
Examine mind wandering modulation effects of monaural beat stimulation using the Mind Wandering Questionnaire
Description
The Mind Wandering Questionnaire is a short-form scale intended to measure the propensity to mind wander (Mrazek et al., 2013). The questionnaire consists of five items that evaluate trait levels of mind wandering. Trait mind wandering is scored across a 6-point Likert scale (1: almost never; 2: very infrequently; 3: somewhat infrequently; 4: somewhat frequently; 5: very frequently; 6: almost always). Patients completed this questionnaire, also at the beginning and end of each week.
Time Frame
3 years
Title
Examine daily momentary subjective levels of anxiety, mood and pain modulation effects of monaural beat stimulation using the Mind Wandering Questionnaire
Description
The Rogers' Happy/ Sad Face Scale is a visual-numeric scale that was intended to capture the momentary subjective levels of anxiety, mood and pain. Patients had to grade their feelings according to a corresponding face icon which represented a 'happy face' at the most positive end (value of 0) of the graded scale, all the way to a 'crying face' icon at the most negative end of the scale (value of 4). Patients completed this scale twice daily, once immediately prior to the auditory stimulation, and then immediately after the stimulation had concluded.
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria are the international criteria of a behavioral variant of FTD according to Raskovsky and colleagues (2011), which include: 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). Exclusion Criteria: Exclusion criteria include the presence of a non-neurodegenerative psychiatric disease that can better explain the behavioral abnormalities or evidence of biomarkers with clear evidence of Alzheimer's disease or other neurodegenerative process
Facility Information:
Facility Name
Juergen Fell
City
Bonn
State/Province
NRW
ZIP/Postal Code
53127
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data that cannot be identified will be made available upon request
IPD Sharing Time Frame
Available immediately and for the next 4 years
IPD Sharing Access Criteria
Email and confirmation of usage.

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Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

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