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CompletedNCT02463981Updated Feb 9, 2022Results posted

Anterior Insula Regulation and Pain Empathy

An interventional study of real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands) in Anterior Insula Activity During Regulation and Empathic Responses After Anterior Insula Regulation, sponsored by University of Electronic Science and Technology of China. Completed. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by University of Electronic Science and Technology of China · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts pain empathy.

Read the detailed description

In the present study, investigators plan to use the real-time fMRI neurofeedback to train healthy subjects to learn volitional control over their own anterior insula (AI) activity. Then the effect of AI regulation will assessed by examining subjects' empathic responses and functional connectivity changes. Subjects were separated into two groups randomly. While the experimental group received specific neurofeedback from their own AI, the control group received sham NF from an unspecific region.

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Conditions studied

  • Anterior Insula Activity During Regulation
  • Empathic Responses After Anterior Insula Regulation
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In context

Lead sponsor

University of Electronic Science and Technology of China is the lead sponsor of 109 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion criteria

Exclusion Criteria:

  • history of head injury;
  • claustrophobia;
  • pregnancy;
  • medical or psychiatric illness.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    neurofeedback training

    Neurofeedback training group receives neurofeedback from their own anterior insula.

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

  • Sham comparator
    sham control

    Sham control group receives sham neurofeedback from a large control brain region.

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

Interventions

  • Devicereal-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)
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What researchers measure

Primary outcomes

  1. Neural Activity of Anterior Insula During Neorofeedback Training

    Neural activity was analyzed using standard fMRI analysis procedure that examine neural activity during training of anterior insula regulation. The measures include BOLD signal analysis (reflecting neural activity strengths) as well as functional connectivity analysis (that examine the interaction between different brain regions).

    Time frame: three days.

  2. Pain Empathy Rating Scores

    Subjects were required to rate their empathic feeling towards painful pictures on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very painful). The effects of training on the empathy for pain were analyzed comparing the feedback group with the controls group. For each subject differences were calculated between pictures that were preceded by a training compared to a no-training block. Within the context of the present design we expected that training-induced increases in anterior insula activity should lead to higher pain empathy ratings in the training group as compared to the control group.

    Time frame: three days.

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Results

Posted Jan 4, 2018

Participant flow

Participant flow — Overall Study
MilestoneNeurofeedback TrainingSham Control
Started2116
Completed1814
Not completed32

Outcome measures

PrimaryNeural Activity of Anterior Insula During Neorofeedback Training

Neural activity was analyzed using standard fMRI analysis procedure that examine neural activity during training of anterior insula regulation. The measures include BOLD signal analysis (reflecting neural activity strengths) as well as functional connectivity analysis (that examine the interaction between different brain regions).

Time frame:
three days.
Reported as:
Mean · percentage of BOLD signal change
Neural Activity of Anterior Insula During Neorofeedback Training
percentage of BOLD signal changeNeurofeedback TrainingSham Control
Neural Activity of Anterior Insula During Neorofeedback Training0.077 ± 0.0160.026 ± 0.018
PrimaryPain Empathy Rating Scores

Subjects were required to rate their empathic feeling towards painful pictures on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very painful). The effects of training on the empathy for pain were analyzed comparing the feedback group with the controls group. For each subject differences were calculated between pictures that were preceded by a training compared to a no-training block. Within the context of the present design we expected that training-induced increases in anterior insula activity should lead to higher pain empathy ratings in the training group as compared to the control group.

Time frame:
three days.
Reported as:
Mean · units on a scale
Pain Empathy Rating Scores
units on a scaleNeurofeedback TrainingSham Control
Pain Empathy Rating Scores0.249 ± 0.107-0.09 ± 0.122

Adverse events

Collected over three days - subjects were required to come back to the lab after two days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Neurofeedback Training—0/21 (0%)0/21 (0%)
Sham Control—0/16 (0%)0/16 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Neurofeedback TrainingSham ControlTotal
Mean22.2 ± 0.321.7 ± 0.521.95 ± 0.4
Sex: Female, Male
Sex: Female, Male(Participants)Neurofeedback TrainingSham ControlTotal
Female11718
Male10919
Region of Enrollment
Region of Enrollment(Participants)Neurofeedback TrainingSham ControlTotal
China211637
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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02463981
Lead sponsor
University of Electronic Science and Technology of China
Responsible party
Shuxia Yao (PhD student, University of Electronic Science and Technology of China) — Principal investigator
First posted
Jun 8, 2015
Start date
Jun 2015
Primary completion
Jul 2015
Completion
Jul 2015
Results posted
Jan 4, 2018
Last update
Feb 9, 2022

Study contacts

Keith Kendrick, Dr.
principal investigator · University of Electronic Science and Technology of China
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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