Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 2:49 AM
Ignite Modification Date: 2025-12-25 @ 2:49 AM
NCT ID: NCT04303533
Brief Summary: Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many individuals exposed to aversive events. The severity of PTSD symptoms is positively correlated with amygdala activation. More severe PTSD symptoms following exposure to stressful events, are associated with amygdala hyper-responsivity prior to exposure. A possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Previous work in the investigator's lab established a NF training procedure that utilizes the temporal abilities of EEG with the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to self-regulate amygdala activity and to improve emotional regulation in a healthy population. The current study aims to investigate the potential of this method as a therapeutic intervention for PTSD among men with a history of childhood sexual abuse (CSA).
Detailed Description: Pretreatment phase- All participants will undergo clinician evaluation and self-report measures in TASMC. In addition, they will receive a WatchPAT (wearable technology) for tracking sleep for 2 nights. Participants will receive 10 sessions of NF-EFP once a week for ten weeks. NF-EFP sessions: For the duration of each NF-EFP session the participant will be seated comfortably in front of a computer screen. A staff member will explain the goal of the meeting to the participant, present the equipment to be used and describe the course of the meeting. The EEG-NF practice will consist of four-minute segments repeated for up to 30 minutes. During each practice segment the participant will be asked to modify visual media that provides feedback on the degree of successful brain training. The duration of one session is approximately 45 minutes. Post treatment phase -All participants will undergo clinician evaluation and self-report measures in TASMC. In addition, they will receive a WatchPAT (wearable technology) for tracking sleep for 2 nights.
Study: NCT04303533
Study Brief:
Protocol Section: NCT04303533