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

NCT05214833 | Unknown

• 1 other identifier: 2021-02093
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychogenic Seizure; Epilepsy, Temporal Lobe; Health, Subjective

Keywords

sense of agency

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Age in years

  Before neurofeedback

• Sex (male/female)

  Before neurofeedback

• Years of education

  Before neurofeedback

Study Arms (2)

Real neurofeedback

EXPERIMENTAL

The first arm will receive real neurofeedback.

Behavioral: Real Neurofeedback

Sham neurofeedback

SHAM COMPARATOR

The second arm will receive sham neurofeedback.

Behavioral: Sham Neurofeedback

Interventions

Real Neurofeedback BEHAVIORAL

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

Real neurofeedback

Sham Neurofeedback BEHAVIORAL

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

Sham neurofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ETH Zurich: lead
• Swiss Epilepsy Centre - Klinik Lengg: collaborator

Study Sites (1)

ETH Zurich

Zurich, Canton of Zurich, 8057, Switzerland

RECRUITING

MeSH Terms

Conditions

Psychogenic Nonepileptic Seizures; Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 31, 2022
• Study Start: February 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)