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

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.

Study Overview

• Status: Recruiting
• Conditions: Health, Subjective; Epilepsy, Temporal Lobe; Psychogenic Seizure
• Intervention / Treatment: Behavioral: Real Neurofeedback; Behavioral: Sham Neurofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8057
      • Recruiting
      • ETH Zurich
      • Contact: Giuseppe A Zito, PhD; Phone Number: +41766691816; Email: zito.giuseppe.angelo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real neurofeedback; The first arm will receive real neurofeedback.	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 Comparator: Sham neurofeedback; The second arm will receive sham neurofeedback.	Behavioral: Sham Neurofeedback; During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Electrophysiological data, i.e., EEG power in alpha band	Brain activity	Before and immediately after neurofeedback
Change in Electrophysiological data, i.e., EEG power in theta band	Brain activity	Before and immediately after neurofeedback
Change in Electrophysiological data, i.e., EEG power in gamma band	Brain activity	Before and immediately after neurofeedback
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age in years	Baseline variable	Before neurofeedback
Sex (male/female)	Baseline variable	Before neurofeedback
Years of education	Baseline variable	Before neurofeedback
Medication status	Baseline variable, list of drugs currently in use by the participant	Before neurofeedback
Anxiety	Baseline variable assessed with the State-Trait Anxiety Inventory (STAI). Minimum value (20) = no anxiety. Maximum value (80) = high anxiety.	Before neurofeedback
Mood	Baseline variable assessed with a visual analog scale. Minimum value (0) = bad mood. Maximum value (100) = good mood.	Before neurofeedback
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
Daily rate of cigarettes	Baseline variable assessed in number of cigarettes/day	Before neurofeedback

Collaborators and Investigators

• Sponsor: ETH Zurich
• Collaborators: Swiss Epilepsy Centre - Klinik Lengg

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: sense of agency
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Neurologic Manifestations; Epilepsy; Epilepsies, Partial; Seizures; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 2021-02093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No