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

March 21, 2022 updated by: Giuseppe Angelo Zito, ETH Zurich
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Electrophysiological data, i.e., EEG power in alpha band
Time Frame: Before and immediately after neurofeedback
Brain activity
Before and immediately after neurofeedback
Change in Electrophysiological data, i.e., EEG power in theta band
Time Frame: Before and immediately after neurofeedback
Brain activity
Before and immediately after neurofeedback
Change in Electrophysiological data, i.e., EEG power in gamma band
Time Frame: Before and immediately after neurofeedback
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
Time Frame: Before and immediately after neurofeedback
Behavioural performance in response to manipulation of the Sense of Agency (SoA)
Before and immediately after neurofeedback

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age in years
Time Frame: Before neurofeedback
Baseline variable
Before neurofeedback
Sex (male/female)
Time Frame: Before neurofeedback
Baseline variable
Before neurofeedback
Years of education
Time Frame: Before neurofeedback
Baseline variable
Before neurofeedback
Medication status
Time Frame: Before neurofeedback
Baseline variable, list of drugs currently in use by the participant
Before neurofeedback
Anxiety
Time Frame: Before neurofeedback
Baseline variable assessed with the State-Trait Anxiety Inventory (STAI). Minimum value (20) = no anxiety. Maximum value (80) = high anxiety.
Before neurofeedback
Mood
Time Frame: Before neurofeedback
Baseline variable assessed with a visual analog scale. Minimum value (0) = bad mood. Maximum value (100) = good mood.
Before neurofeedback
Sleep habits
Time Frame: Before neurofeedback
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
Time Frame: Before neurofeedback
Baseline variable assessed in number of cigarettes/day
Before neurofeedback

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ETH Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss Epilepsy Centre - Klinik Lengg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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