Trial Outcomes & Findings for Anterior Insula Regulation and Pain Empathy (NCT NCT02463981)
NCT ID: NCT02463981
Last Updated: 2022-02-09
Results Overview
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).
COMPLETED
NA
37 participants
three days.
2022-02-09
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
16
|
|
Overall Study
COMPLETED
|
18
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anterior Insula Regulation and Pain Empathy
Baseline characteristics by cohort
| Measure |
Neurofeedback Training
n=21 Participants
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)
|
Sham Control
n=16 Participants
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)
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.2 years
STANDARD_DEVIATION 0.3 • n=5 Participants
|
21.7 years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
21.95 years
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Neurofeedback Training
n=18 Participants
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)
|
Sham Control
n=14 Participants
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)
|
|---|---|---|
|
Neural Activity of Anterior Insula During Neorofeedback Training
|
0.077 percentage of BOLD signal change
Standard Error 0.016
|
0.026 percentage of BOLD signal change
Standard Error 0.018
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Neurofeedback Training
n=18 Participants
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)
|
Sham Control
n=14 Participants
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)
|
|---|---|---|
|
Pain Empathy Rating Scores
|
0.249 units on a scale
Standard Error 0.107
|
-0.09 units on a scale
Standard Error 0.122
|
Adverse Events
Neurofeedback Training
Sham Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place