Effects of ASMR on the Default Mode Network | NCT05266508

Studies
Effects of ASMR on the Default Mode Network

NCT05266508

Sponsor

BDH-Klinik Hessisch Oldendorf

Status

Completed

Last Update Posted

Aug 7, 2024Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Autonomous Sensory Meridian Response
Audiobook

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

May 2, 2022Actual

Completion Date

Aug 15, 2023Actual

First Submitted Date

Feb 23, 2022

First Submission Date that Met QC Criteria

Feb 23, 2022

First Posted Date

Mar 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2024

Last Update Posted Date

Aug 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study investigates the effects of Autonomous Sensory Meridian Response (ASMR) stimulation on resting-state brain networks. Therefore, two resting-state fMRI scans are measured in healthy adults. Before each fMRI scan, subjects listen either to ASMR typical sounds or an audio-book (randomized cross-over-design). It is expected to find changes in the functional connectivity of the Default Mode Network caused by passive listening to ASMR.

Detailed Description

ASMR describes a phenomenon of a perceived tingling caused by visual or auditory stimulation. This sensation can spread from the neck to the scalp and further to the back and the extremities. The triggering sound often consists of acoustic sounds (crackle, whisper, light nail-tapping) or visual images (e.g., someone is combing their hair), leading to a calm and relaxing feeling. Although ASMR is ubiquitous in platforms like "YouTube", there are just a few studies investigating the effects of ASMR. In one of those studies, Smith and colleagues examined the Default Mode Network of 11 subjects with ASMR stimulation and compared the outcome with a control group consisting of 11 subjects. They found reduced functional connectivity in the ASMR group compared to the control group. Furthermore, the connectivity between the occipital, frontal and temporal cortex was increased.

In the present study, fMRI is used to examine the effects of ASMR stimulation in a randomized cross-over design. Half of the subjects (n=14) receive the ASMR stimulation first, and then the control stimulation (audiobook). The other half of the subjects (n=14) listens to the control stimulation (audiobook) first and afterward to the ASMR stimulation. Typical "tingling" triggering sounds are presented via MRI-compatible headphones. Those sounds can consist of different noises (e.g., whisper, scratching, and knocking).

The primary outcome measure is a change in the functional connectivity of the Default Mode Network as a response to the ASMR stimulation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changed functional connectivity	Functional connectivity is measured using resting-state fMRI	45 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults aged 18 to 99

Exclusion Criteria:

mental disorders (dementia, depression)
MRI contraindications
claustrophobia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects aged 18 to 99

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens D. Rollnik, MD	BDH-Clinik Hessisch Oldendorf	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BDH-Clinic Hessisch Oldendorf		Hessisch Oldendorf		31840	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30931592	Background	Smith SD, Fredborg BK, Kornelsen J. Atypical Functional Connectivity Associated with Autonomous Sensory Meridian Response: An Examination of Five Resting-State Networks. Brain Connect. 2019 Jul;9(6):508-518. doi: 10.1089/brain.2018.0618. Epub 2019 May 7.