Menu
Recruiting NCT07364084

Real-time Neurofeedback Training of the Medial Prefrontal Cortex Based on Imagined Social Support

No phase Interventional Healthy Neurofeedback

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: real-time fMRI sham-controlled neurofeedback training procedure.
Who it may be relevant to
Registry conditions: Healthy, Neurofeedback. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Self-modulation of the mPFC Using Rt-fMRI NF Training to Improve Negative Anticipation for Future Events

Overview

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.

Detailed description

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 .

Interventions

  • Procedure real-time fMRI sham-controlled neurofeedback training procedure
    real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)

Primary outcome measures

  • Neural activity of the medial prefrontal cortex (mPFC) based on blood oxygen level-dependent (BOLD) signal [Time frame: 1 hour]
Secondary outcome measures (1)
  • Training-related changes in anticipated anxiety [Time frame: 1 hour]

Eligibility criteria

Inclusion criteria

  • -Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion criteria

  • History of brain injury
  • Psychiatric or Neurological Disorder
  • Contraindications for MRI
  • Regular use of psychotropic substances (medication, drugs)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

China · 1 center
  • University of Electronic Science and Technology of China(UESTC), Chengdu, Sichuan 611731 — Chengdu

Identifiers

NCT: NCT07364084 · BAM_lab_NF_06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗