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

Sponsor

ETH Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT05214833

Collaborator

Swiss Epilepsy Centre - Klinik Lengg (Other)

225

Enrollment

Location

Arms

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psychogenic Seizure Epilepsy, Temporal Lobe Health, Subjective	Behavioral: Real Neurofeedback Behavioral: Sham Neurofeedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two arms will be investigated. The first one will receive real neurofeedback. The second one will receive sham neurofeedback (comparator). During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.Two arms will be investigated. The first one will receive real neurofeedback. The second one will receive sham neurofeedback (comparator). During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Electrophysiological data, i.e., EEG power in alpha band [Before and immediately after neurofeedback]
Brain activity
Change in Electrophysiological data, i.e., EEG power in theta band [Before and immediately after neurofeedback]
Brain activity
Change in Electrophysiological data, i.e., EEG power in gamma band [Before and immediately after neurofeedback]
Brain activity
Change in the subjective perception of the Sense of Agency, i.e., visual analog scale assessing how much control participants feel over the game [Before and immediately after neurofeedback]
Behavioural performance in response to manipulation of the Sense of Agency (SoA)

Other Outcome Measures

Age in years [Before neurofeedback]
Baseline variable
Sex (male/female) [Before neurofeedback]
Baseline variable
Years of education [Before neurofeedback]
Baseline variable
Medication status [Before neurofeedback]
Baseline variable, list of drugs currently in use by the participant
Anxiety [Before neurofeedback]
Baseline variable assessed with the State-Trait Anxiety Inventory (STAI). Minimum value (20) = no anxiety. Maximum value (80) = high anxiety.
Mood [Before neurofeedback]
Baseline variable assessed with a visual analog scale. Minimum value (0) = bad mood. Maximum value (100) = good mood.
Sleep habits [Before neurofeedback]
Baseline variable assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value (0) = good sleep quality. Maximum value (20) = poor sleep quality.
Daily rate of cigarettes [Before neurofeedback]
Baseline variable assessed in number of cigarettes/day

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ETH Zurich	Zurich	ZH	Switzerland	8057

Sponsors and Collaborators

ETH Zurich
Swiss Epilepsy Centre - Klinik Lengg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giuseppe Angelo Zito, Principal Investigator, ETH Zurich

ClinicalTrials.gov Identifier:

NCT05214833

Other Study ID Numbers:

2021-02093

First Posted:

Jan 31, 2022

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Giuseppe Angelo Zito, Principal Investigator, ETH Zurich

sense of agency

Additional relevant MeSH terms:

Seizures

Epilepsy, Temporal Lobe

Study Results

No Results Posted as of Apr 1, 2022