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Randomized active-sham controlled between-subject real-time fMRI neurofeedback trial aiming to modulate activity in the medial prefrontal cortex (mPFC) to improve subjective negative anticipation.
A double-blinded, placebo-controlled, between-subject design will be employed in this study. In a randomized order, a total of 60 healthy subjects will be recruited and assigned to the experimental group (EG; N=30), which receives real feedback from the medial prefrontal cortex (mPFC), or the sham control group (CG; N=30) which receives sham feedback from an unrelated brain region. Neurofeedback training consists of 1 baseline session without feedback (also as a localizer task), 4 training sessions with intermittent feedback and 1 transfer session without feedback. Each NF run includes 5 regulation blocks and 5 baseline blocks. Each trial starts with a jittered fixation cross (2~8 s), a modulation block (i.e. regulation or baseline; 30 s) without continous feedback, and a intermittent feedback period (4s) to display the mean activiation of the mPFC/control region during the regulation block compared with baseline block. Objectives are to determine (1) if subjects in the neurofeedback (NF) group can gain volitional control over the mPFC activation using imagined social support as regulation strategy, (2) whether successful increased modulation of the mPFC could improve negative anticipation and sense of control for future events .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback training | Experimental | Participants in the neurofeedback training group are instructed to regulate their medial prefrontal cortex activity based on the visual intermittent neurofeedback. |
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| Sham control | Sham Comparator | Participants in the sham control group receive the same instruction and perform the same regulation strategy based on neurofeedback from an unrelated region (i.e. primary motor cortex) which is not involved in episodic imagination in related to social support (a controlled sham region). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real-time fMRI sham-controlled neurofeedback training procedure | Procedure | real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands) |
| Measure | Description | Time Frame |
|---|---|---|
| Neural activity of the medial prefrontal cortex (mPFC) based on blood oxygen level-dependent (BOLD) signal | Training-induced changes in mPFC activity will be assessed by analyzing BOLD-level activation of the mPFC | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Training-related changes in anticipated anxiety | Participants will be required to rate the anticipated anxiety of future events using a Likert Scale ranging from 1 to 9 (1 = not at all anxious) and 9 = very anxious). | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Becker, Dr | Contact | 86-28-61830670 | ben_becker@gmx.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Electronic Science and Technology of China(UESTC), Chengdu, Sichuan 611731 | Recruiting | Chengdu | Sichuan | 611731 | China |
Corresponding individual level data will be made available upon request.
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