Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; bvFTD
• Intervention / Treatment: Other: Auditory beat stimulation: 8Hz monaural 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • Juergen Fell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Monaural beat stimulation; 20 min sound recording of 8Hz monaural beat	Other: Auditory beat stimulation: 8Hz monaural beat stimulation; Auditory beat stimulation is a reversible, non-invasive application of sound to the ears.
Sham Comparator: Control; 20 min sound recording of 220Hz pure sine wave	Other: Auditory beat stimulation: 8Hz monaural beat stimulation; Auditory beat stimulation is a reversible, non-invasive application of sound to the ears.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: 308/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No