Clinical trial NCT05214833: Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback
Official title: Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychogenic Seizure
Epilepsy, Temporal Lobe
Health, Subjective
Keywords: sense of agency
Lead sponsor: ETH Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Epilepsy Centre - Klinik Lengg
First posted: 2022-01-31
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change in Electrophysiological data, i.e., EEG power in alpha band
timeFrame: Before and immediately after neurofeedback
measure: Change in Electrophysiological data, i.e., EEG power in theta band
timeFrame: Before and immediately after neurofeedback
measure: Change in Electrophysiological data, i.e., EEG power in gamma band
timeFrame: Before and immediately after neurofeedback
measure: Change in the subjective perception of the Sense of Agency, i.e., visual analog scale assessing how much control participants feel over the game
timeFrame: Before and immediately after neurofeedback
Secondary outcomes:
Other outcomes:
measure: Age in years
timeFrame: Before neurofeedback
measure: Sex (male/female)
timeFrame: Before neurofeedback
measure: Years of education
timeFrame: Before neurofeedback
measure: Medication status
timeFrame: Before neurofeedback
measure: Anxiety
timeFrame: Before neurofeedback
measure: Mood
timeFrame: Before neurofeedback
measure: Sleep habits
timeFrame: Before neurofeedback
measure: Daily rate of cigarettes
timeFrame: Before neurofeedback
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
state: ZH
Study officials:
References: