Skip to content

Anterior Insula Regulation and Pain Empathy

Voluntary Anterior Insula Regulation Impacts Pain Empathy and Functional Connectivity: a Real-time fMRI Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02463981
Enrollment
37
Registered
2015-06-08
Start date
2015-06-30
Completion date
2015-07-31
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Insula Activity During Regulation, Empathic Responses After Anterior Insula Regulation

Brief summary

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

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.

Interventions

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

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion criteria

* history of head injury; * claustrophobia; * pregnancy; * medical or psychiatric illness.

Design outcomes

Primary

MeasureTime frameDescription
Neural Activity of Anterior Insula During Neorofeedback Trainingthree days.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).
Pain Empathy Rating Scoresthree days.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.

Participant flow

Participants by arm

ArmCount
Neurofeedback Training
Neurofeedback training group receives neurofeedback from their own anterior insula. real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)
21
Sham Control
Sham control group receives sham neurofeedback from a large control brain region. real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)
16
Total37

Baseline characteristics

CharacteristicNeurofeedback TrainingSham ControlTotal
Age, Continuous22.2 years
STANDARD_DEVIATION 0.3
21.7 years
STANDARD_DEVIATION 0.5
21.95 years
STANDARD_DEVIATION 0.4
Region of Enrollment
China
21 Participants16 Participants37 Participants
Sex: Female, Male
Female
11 Participants7 Participants18 Participants
Sex: Female, Male
Male
10 Participants9 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 210 / 16
serious
Total, serious adverse events
0 / 210 / 16

Outcome results

Primary

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.

Population: From the initial population of 37 participants 5 had to be excluded because of high head movement during fMRI acquisition. This is a standard procedure in fMRI studies given that the analysis is very susceptible to movement artifacts.

ArmMeasureValue (MEAN)Dispersion
Neurofeedback TrainingNeural Activity of Anterior Insula During Neorofeedback Training0.077 percentage of BOLD signal changeStandard Error 0.016
Sham ControlNeural Activity of Anterior Insula During Neorofeedback Training0.026 percentage of BOLD signal changeStandard Error 0.018
Primary

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.

Population: From the initial population of 37 participants 5 had to be excluded because of high head movement during fMRI acquisition. This is a standard procedure in fMRI studies given that the analysis is very susceptible to movement artifacts.

ArmMeasureValue (MEAN)Dispersion
Neurofeedback TrainingPain Empathy Rating Scores0.249 units on a scaleStandard Error 0.107
Sham ControlPain Empathy Rating Scores-0.09 units on a scaleStandard Error 0.122

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026