Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

Anxiety Clinical Trial

Official title:

Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05917886
• Other study ID #: 308/20
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2023
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Other:
• Auditory beat stimulation: 8Hz monaural beat stimulation
Auditory beat stimulation is a reversible, non-invasive application of sound to the ears.

Locations

Country	Name	City	State
Germany	Juergen Fell	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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