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

ETH Zurich

Status: Enrolling

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

Treatments: Behavioral: Real Neurofeedback; Behavioral: Sham Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05214833

2021-02093

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 2 patient groups

Real neurofeedback

Experimental group

Description:

The first arm will receive real neurofeedback.

Treatment:

Behavioral: Real Neurofeedback

Sham neurofeedback

Sham Comparator group

Description:

The second arm will receive sham neurofeedback.

Treatment:

Behavioral: Sham Neurofeedback