Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

NCT05917886 | Completed

• 1 other identifier: 308/20
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; bvFTD

Outcome Measures

Primary Outcomes (4)

• 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.

  3 years

• 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.

  3 years

• 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.

  3 years

• 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.

  3 years

Study Arms (2)

Monaural beat stimulation

ACTIVE COMPARATOR

20 min sound recording of 8Hz monaural beat

Other: Auditory beat stimulation: 8Hz monaural beat stimulation

Control

SHAM COMPARATOR

20 min sound recording of 220Hz pure sine wave

Other: Auditory beat stimulation: 8Hz monaural beat stimulation

Interventions

Auditory beat stimulation: 8Hz monaural beat stimulation OTHER

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

Control; Monaural beat stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Juergen Fell

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants were unaware which auditory beat stimulation condition they received in which order.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priniciple Investigator

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

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 26, 2023
• Study Start: January 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available immediately and for the next 4 years
• Access Criteria: Email and confirmation of usage.

Locations

DE (1)