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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psychogenic Seizure, Epilepsy, Temporal Lobe, Health, Subjective

Intervention / Treatment
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* Behavioral: Real Neurofeedback
* Behavioral: Sham Neurofeedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real neurofeedback<br>The first arm will receive real neurofeedback. | Behavioral: Real Neurofeedback<br>* During neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants.<br>|
| Sham Comparator: Sham neurofeedback<br>The second arm will receive sham neurofeedback. | Behavioral: Sham Neurofeedback<br>* During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sense of agency