Anterior Insula Activity During RegulationNCT02463981

Anterior Insula Regulation and Pain Empathy

A study testing real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands) in people with Anterior Insula Activity During Regulation and Empathic Responses After Anterior Insula Regulation, run by University of Electronic Science and Technology of China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts pain empathy. Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Anterior Insula Activity During Regulation, Empathic Responses After Anterior Insula Regulation
What is being tested?: real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: No sites listed yet
Study dates: Jun 2015to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy subjects without past or current psychiatric or neurological disorders

Who cannot join

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

About this study

Official title: 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.

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.

Conditions: Anterior Insula Activity During Regulation, Empathic Responses After Anterior Insula Regulation
Being tested: real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02463981
Study group	Role	What they receive
neurofeedback training	Experimental	Neurofeedback training group receives neurofeedback from their own anterior insula. Receives: Device: real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)
sham control	Sham comparator	Sham control group receives sham neurofeedback from a large control brain region. Receives: Device: real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: three days.
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.
Measured: three days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Jul 2015

First posted8 Jun 2015 (estimated)
Study startJun 2015
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anterior Insula Activity During RegulationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02463981
Sponsor's protocol ID: UESTC-SCAN-02
Status last verified: Feb 2022
First submitted: 29 May 2015
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Voluntary Anterior Insula Regulation Impacts Pain Empathy and Functional Connectivity: a Real-time fMRI Study
ClinicalTrials.gov ID: NCT02463981
Acronym / sponsor ID: UESTC-SCAN-02
Conditions: Anterior Insula Activity During Regulation, Empathic Responses After Anterior Insula Regulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: University of Electronic Science and Technology of ChinaUniversity, hospital or other
Study start: Jun 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 8 Jun 2015 (estimated)
Results: Posted 4 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
neurofeedback training	Experimental	Device: real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)Neurofeedback training group receives neurofeedback from their own anterior insula.
sham control	Sham comparator	Device: real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)Sham control group receives sham neurofeedback from a large control brain region.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy subjects without past or current psychiatric or neurological disorders

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)	Device	neurofeedback training, sham control

Primary outcome

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).
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.

Results and safety

Results posted to the registry on 4 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neurofeedback Training	21	18
Sham Control	16	14

Primary outcome: Neural Activity of Anterior Insula During Neorofeedback Training

Time frame: three days.. Mean (Standard Error). Unit: percentage of BOLD signal change

Measure	Neurofeedback Training n = 18	Sham Control n = 14
Value	0.077 (0.016)	0.026 (0.018)

Population analysed: 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.

Primary outcome: Pain Empathy Rating Scores

Time frame: three days.. Mean (Standard Error). Unit: units on a scale

Measure	Neurofeedback Training n = 18	Sham Control n = 14
Value	0.249 (0.107)	-0.09 (0.122)

Adverse events

Time frame: three days - subjects were required to come back to the lab after two days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neurofeedback Training	0 of 21 (0%)	0 of 21 (0%)	Not reported
Sham Control	0 of 16 (0%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Keith Kendrick, Dr. principal investigator

University of Electronic Science and Technology of China

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neural Activity of Anterior Insula During Neorofeedback Training (time frame: three days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02463981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.