To study the effect of neurofeedback training on depression scores and prefrontal cortical activity in depression: a randomized control study

The study aims to explore the use of functional near-infrared spectroscopy (fNIRS) as a tool for neurofeedback training in depression. The study is a single-center, open-label, randomized trial conducted at the Cognitive Neurophysiology Lab, Department of Physiology, All India Institute of Medical Sciences, Nagpur. It aims to investigate the effect of neurofeedback training on prefrontal cortical activity in adults with depression. Participants will be recruited from the Department of Psychiatry and will be given ID codes to maintain confidentiality. The study will have two groups: Group A (Neurofeedback training) and Group B (Sham training), with all patients receiving standard care of treatment. The neurofeedback training will involve participants modulating their prefrontal cortical activity based on real-time feedback, while the sham training will mimic the same settings without the active cognitive component.Neurofeedback training involves the patient sitting in front of a screen displaying their real-time prefrontal cortical activity (HbO levels) using functional near-infrared spectroscopy (fNIRS). The patient is instructed to focus on this activity and attempt to modulate it, with the sessions consisting of 30 seconds of rest, 30 seconds of activation, and 30 seconds of rest, repeated 20 times. The patient is provided with strategies to increase prefrontal cortical activity and is given practice rounds to learn before starting the neurofeedback session.

Sham training also requires the patient to sit in front of a similar screen, but the sessions do not include the activation part of their own cortical activity. Instead, the sessions consist of 30 seconds of rest followed by 30 seconds of observing the prefrontal cortical activity of another participant from the neurofeedback group, also repeated 20 times. This mimics the same settings as neurofeedback training but without the active cognitive component.

The study aims to assess the impact of these interventions on depression scores and prefrontal cortical activity, with the neurofeedback training group expected to show improvements in these measures compared to the sham training group. The study will also evaluate the duration of the antidepressant effects of neurofeedback training beyond the 4-week training period.

The study will use functional near-infrared spectroscopy (fNIRS) to measure prefrontal cortical activity, and statistical analysis will be conducted using ANOVA and Krusall wallis tests. The study will have no blinding, and participants will be free to withdraw from the study at any stage without penalty. The data collected will be encrypted and stored locally and on cloud/online backup to maintain confidentiality.