- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02463981
Anterior Insula Regulation and Pain Empathy
February 8, 2022 updated by: Shuxia Yao, University of Electronic Science and Technology of China
Voluntary Anterior Insula Regulation Impacts Pain Empathy and Functional Connectivity: a Real-time fMRI Study
The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts pain empathy.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects without past or current psychiatric or neurological disorders
Exclusion Criteria:
- history of head injury;
- claustrophobia;
- pregnancy;
- medical or psychiatric illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: neurofeedback training
Neurofeedback training group receives neurofeedback from their own anterior insula.
|
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Sham Comparator: sham control
Sham control group receives sham neurofeedback from a large control brain region.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural Activity of Anterior Insula During Neorofeedback Training
Time Frame: three 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).
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three days.
|
Pain Empathy Rating Scores
Time Frame: three 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.
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three days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
May 29, 2015
First Submitted That Met QC Criteria
June 4, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 8, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- UESTC-SCAN-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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