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

Primary Purpose

Psychogenic Seizure, Epilepsy, Temporal Lobe, Health, Subjective

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Real Neurofeedback

Sham Neurofeedback

About this trial

This is an interventional basic science trial for Psychogenic Seizure focused on measuring sense of agency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

ETH ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real neurofeedback

Sham neurofeedback

Arm Description

The first arm will receive real neurofeedback.

The second arm will receive sham neurofeedback.

Outcomes

Primary Outcome Measures

Change in Electrophysiological data, i.e., EEG power in alpha band

Brain activity

Change in Electrophysiological data, i.e., EEG power in theta band

Brain activity

Change in Electrophysiological data, i.e., EEG power in gamma band

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

Behavioural performance in response to manipulation of the Sense of Agency (SoA)

Secondary Outcome Measures

Full Information

NCT ID

NCT05214833

First Posted

November 30, 2021

Last Updated

March 21, 2022

Sponsor

ETH Zurich

Collaborators

Swiss Epilepsy Centre - Klinik Lengg

1. Study Identification

Unique Protocol Identification Number

NCT05214833

Brief Title

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

Acronym

NF-Agency

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

January 31, 2025 (Anticipated)

Study Completion Date

January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

ETH Zurich

Collaborators

Swiss Epilepsy Centre - Klinik Lengg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychogenic Seizure, Epilepsy, Temporal Lobe, Health, Subjective

Keywords

sense of agency

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Real neurofeedback

Arm Type

Experimental

Arm Description

The first arm will receive real neurofeedback.

Arm Title

Sham neurofeedback

Arm Type

Sham Comparator

Arm Description

The second arm will receive sham neurofeedback.

Intervention Type

Behavioral

Intervention Name(s)

Real Neurofeedback

Intervention Description

During neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants.

Intervention Type

Behavioral

Intervention Name(s)

Sham Neurofeedback

Intervention Description

During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.

Primary Outcome Measure Information:

Title

Change in Electrophysiological data, i.e., EEG power in alpha band

Description

Brain activity

Time Frame

Before and immediately after neurofeedback

Title

Change in Electrophysiological data, i.e., EEG power in theta band

Description

Brain activity

Time Frame

Before and immediately after neurofeedback

Title

Change in Electrophysiological data, i.e., EEG power in gamma band

Description

Brain activity

Time Frame

Before and immediately after neurofeedback

Title

Change in the subjective perception of the Sense of Agency, i.e., visual analog scale assessing how much control participants feel over the game

Description

Behavioural performance in response to manipulation of the Sense of Agency (SoA)

Time Frame

Before and immediately after neurofeedback

Other Pre-specified Outcome Measures:

Title

Age in years

Description

Baseline variable

Time Frame

Before neurofeedback

Title

Sex (male/female)

Description

Baseline variable

Time Frame

Before neurofeedback

Title

Years of education

Description

Baseline variable

Time Frame

Before neurofeedback

Title

Medication status

Description

Baseline variable, list of drugs currently in use by the participant

Time Frame

Before neurofeedback

Title

Anxiety

Description

Baseline variable assessed with the State-Trait Anxiety Inventory (STAI). Minimum value (20) = no anxiety. Maximum value (80) = high anxiety.

Time Frame

Before neurofeedback

Title

Mood

Description

Baseline variable assessed with a visual analog scale. Minimum value (0) = bad mood. Maximum value (100) = good mood.

Time Frame

Before neurofeedback

Title

Sleep habits

Description

Baseline variable assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value (0) = good sleep quality. Maximum value (20) = poor sleep quality.

Time Frame

Before neurofeedback

Title

Daily rate of cigarettes

Description

Baseline variable assessed in number of cigarettes/day

Time Frame

Before neurofeedback

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

ETH Zurich

City

Zurich

State/Province

ZIP/Postal Code

8057

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppe A Zito, PhD

Phone

+41766691816

zito.giuseppe.angelo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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

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