NCT05266508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

February 23, 2022

Last Update Submit

August 6, 2024

Conditions

Autonomous Sensory Meridian ResponseAudiobook

Keywords

Autonomous Sensory Meridian ResponseResting-state fMRIDefault Mode Network

Outcome Measures

Primary Outcomes (1)

  • Changed functional connectivity

    Functional connectivity is measured using resting-state fMRI

    45 minutes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy subjects aged 18 to 99

You may qualify if:

  • adults aged 18 to 99

You may not qualify if:

  • mental disorders (dementia, depression)
  • MRI contraindications
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, 31840, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30931592BACKGROUND

Study Officials

  • Jens D. Rollnik, MD

    BDH-Clinik Hessisch Oldendorf

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 4, 2022

Study Start

February 15, 2022

Primary Completion

May 2, 2022

Study Completion

August 15, 2023

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)