NCT05260749

Brief Summary

The main aim of the study is to investigate whether subjects can learn self control of activity of the anterior insula via real-time functional magnetic resonance imaging (fMRI) neurofeedback training based on a regulation strategy of interoceptive processing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable healthy

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

June 16, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

February 8, 2022

Last Update Submit

December 11, 2022

Conditions

Keywords

real-time neurofeedbackanterior insulaInteroceptive Processing

Outcome Measures

Primary Outcomes (1)

  • Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal

    The anterior insula activity induced by neurofeedback training relative to sham feedback training

    1 hour

Secondary Outcomes (2)

  • Confidence rating scores of interoceptive sensitivity

    1 hour

  • pain empathy ratings scores

    1 hour

Study Arms (3)

Neurofeedback training

EXPERIMENTAL

Subjects in the neurofeedback training group are instructed to regulate their anterior insula activity based on the visual neurofeedback.

Procedure: real-time fMRI neurofeedback training procedure

Sham control1

SHAM COMPARATOR

Subjects in the sham control group receive the same instruction but perform the regulation based on neurofeedback from a whole slice of top brain (a controlled sham region).

Procedure: real-time fMRI sham-controlled neurofeedback training procedure

Sham control2

SHAM COMPARATOR

Subjects in the sham control group receive the same instruction but perform the regulation based on neurofeedback from the middle temporal gyrus (a controlled sham region).

Procedure: real-time fMRI sham-controlled neurofeedback training procedure

Interventions

real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)

Neurofeedback training

real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)

Sham control1Sham control2

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects without any past or present psychiatric or neurological disorders

You may not qualify if:

  • History of brain injury Medical or mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, China

Location

Related Publications (1)

  • Zhang Y, Zhang Q, Wang J, Zhou M, Qing Y, Zou H, Li J, Yang C, Becker B, Kendrick KM, Yao S. "Listen to your heart": A novel interoceptive strategy for real-time fMRI neurofeedback training of anterior insula activity. Neuroimage. 2023 Dec 15;284:120455. doi: 10.1016/j.neuroimage.2023.120455. Epub 2023 Nov 10.

Study Officials

  • Yao Shuxia, Dr

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2022

First Posted

March 2, 2022

Study Start

June 16, 2021

Primary Completion

November 15, 2022

Study Completion

December 1, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations