Clinical trial NCT05917886: Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia
Official title: Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
bvFTD
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients participated in both the control and active auditory beat conditions, each lasting 1 week. Conditions were randomised across participants.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Examine anxiety modulation effects of monaural beat stimulation using the State-Trait Anxiety Inventory (STAI-S and T)
timeFrame: 3 years
measure: Examine depression modulation effects of monaural beat stimulation using the Beck Depression Inventory
timeFrame: 3 years
measure: Examine mind wandering modulation effects of monaural beat stimulation using the Mind Wandering Questionnaire
timeFrame: 3 years
measure: Examine daily momentary subjective levels of anxiety, mood and pain modulation effects of monaural beat stimulation using the Mind Wandering Questionnaire
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Juergen Fell
state: NRW
Study officials:
References: