Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback

Health, Subjective Clinical Trial

— NF-Agency  

Official title:

Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214833
• Other study ID #: 2021-02093
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2022
• Source: ETH Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether the sense of agency is sensitive to self-regulation by means of EEG-based neurofeedback. During neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants. The participants can therefore use this information to adapt their performance on the motor task.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (all):

• Aged > 18 years old
• Normal or corrected-to-normal visual acuity
• Willing to participate in the study (by signing the informed consent form)
• Neither caffein, nor alcohol intake 48 hours prior to the experiment
• Regular intake of drugs (except oral contraceptives in women)
• Employed by, or in a dependent relationship with, the sponsor and / or the investigator(s)
• Sufficient knowledge of German or English to understand study documents and instructions.

Inclusion Criteria (patients):

• A diagnosis of temporal epilepsy (TE), documented via video EEG. OR
• A diagnosis of psychogenic non-epileptic seizure (PNES), according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and documented via video EEG.

Exclusion Criteria (all):

• Past surgery in the brain
• History of alcohol or drug abuse
• Incompatibility with EEG recordings, e.g., inability to stay seated for 90 minutes.

Related Conditions & MeSH terms

• Epilepsy, Temporal Lobe
• Health, Subjective
• Psychogenic Seizure
• Seizures

Intervention

Behavioral:
• Real Neurofeedback
During neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants.
• Sham Neurofeedback
During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
ETH Zurich	Swiss Epilepsy Centre - Klinik Lengg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age in years	Baseline variable	Before neurofeedback
Other	Sex (male/female)	Baseline variable	Before neurofeedback
Other	Years of education	Baseline variable	Before neurofeedback
Other	Medication status	Baseline variable, list of drugs currently in use by the participant	Before neurofeedback
Other	Anxiety	Baseline variable assessed with the State-Trait Anxiety Inventory (STAI). Minimum value (20) = no anxiety. Maximum value (80) = high anxiety.	Before neurofeedback
Other	Mood	Baseline variable assessed with a visual analog scale. Minimum value (0) = bad mood. Maximum value (100) = good mood.	Before neurofeedback
Other	Sleep habits	Baseline variable assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value (0) = good sleep quality. Maximum value (20) = poor sleep quality.	Before neurofeedback
Other	Daily rate of cigarettes	Baseline variable assessed in number of cigarettes/day	Before neurofeedback
Primary	Change in Electrophysiological data, i.e., EEG power in alpha band	Brain activity	Before and immediately after neurofeedback
Primary	Change in Electrophysiological data, i.e., EEG power in theta band	Brain activity	Before and immediately after neurofeedback
Primary	Change in Electrophysiological data, i.e., EEG power in gamma band	Brain activity	Before and immediately after neurofeedback
Primary	Change in the subjective perception of the Sense of Agency, i.e., visual analog scale assessing how much control participants feel over the game	Behavioural performance in response to manipulation of the Sense of Agency (SoA)	Before and immediately after neurofeedback