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

U

University of Electronic Science and Technology of China

Status

Enrolling

Conditions

Healthy
Neurofeedback

Treatments

Procedure: real-time fMRI sham-controlled neurofeedback training procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT07364084
BAM_lab_NF_06

Details and patient eligibility

About

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.

Full 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 .

Enrollment

60 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Neurofeedback training
Experimental group
Description:
Participants in the neurofeedback training group are instructed to regulate their medial prefrontal cortex activity based on the visual intermittent neurofeedback.
Treatment:
Procedure: real-time fMRI sham-controlled neurofeedback training procedure
Sham control
Sham Comparator group
Description:
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).
Treatment:
Procedure: real-time fMRI sham-controlled neurofeedback training procedure

Trial contacts and locations

1

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Central trial contact

Benjamin Becker, Dr

Data sourced from clinicaltrials.gov

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