Psychogenic SeizureNF-AgencyNCT05214833
Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback
A study testing Real Neurofeedback in people with Psychogenic Seizure and Epilepsy, Temporal Lobe, run by ETH Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychogenic Seizure, Epilepsy, Temporal Lobe, Health, Subjective
- What is being tested?
- Real Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
ETH Zurich
Zurich, Canton of Zurich, 8057
Giuseppe A Zito, PhD, +41766691816, zito.giuseppe.angelo@gmail.com
About this study
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.
- Being tested
- Real Neurofeedback, Sham Neurofeedback
- Keywords
- sense of agency
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real NeurofeedbackBehavioural
During neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants.
Sham NeurofeedbackBehavioural
During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Real neurofeedback | Experimental | The first arm will receive real neurofeedback. Receives: Behavioral: Real Neurofeedback |
| Sham neurofeedback | Sham comparator | The second arm will receive sham neurofeedback. Receives: Behavioral: Sham Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electrophysiological data, i.e., EEG power in alpha band
Brain activity
Measured: Before and immediately after neurofeedback
Change in Electrophysiological data, i.e., EEG power in theta band
Brain activity
Measured: Before and immediately after neurofeedback
Change in Electrophysiological data, i.e., EEG power in gamma band
Brain activity
Measured: 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)
Measured: Before and immediately after neurofeedback
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Feb 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychogenic SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETH Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Epilepsy Centre - Klinik Lengg
- Responsible party
- Principal investigator, Giuseppe Angelo Zito, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214833
- Sponsor's protocol ID
- 2021-02093
- Acronym
- NF-Agency
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback
- ClinicalTrials.gov ID
- NCT05214833
- Acronym / sponsor ID
- NF-Agency / 2021-02093
- Keywords
- sense of agency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- ETH ZurichUniversity, hospital or other
- Collaborators
- Swiss Epilepsy Centre - Klinik Lengg
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real neurofeedback | Experimental | Behavioral: Real NeurofeedbackThe first arm will receive real neurofeedback. |
| Sham neurofeedback | Sham comparator | Behavioral: Sham NeurofeedbackThe second arm will receive sham neurofeedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (3 listed)
- Past surgery in the brain
- History of alcohol or drug abuse
- Incompatibility with EEG recordings, e.g., inability to stay seated for 90 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real NeurofeedbackDuring neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants. | Behavioural | Real neurofeedback |
| Sham NeurofeedbackDuring sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity. | Behavioural | Sham neurofeedback |
Primary outcome
Change in Electrophysiological data, i.e., EEG power in alpha band
Time frame: Before and immediately after neurofeedback
Brain activity
Change in Electrophysiological data, i.e., EEG power in theta band
Time frame: Before and immediately after neurofeedback
Brain activity
Change in Electrophysiological data, i.e., EEG power in gamma band
Time frame: Before and immediately after neurofeedback
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
Time frame: Before and immediately after neurofeedback
Behavioural performance in response to manipulation of the Sense of Agency (SoA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Psychogenic Seizure
RecruitingEarly Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Functional Neurological Symptom Disorder, Functional Seizures
Recruiting
Modulating Movement Intention Via Cortical Stimulation
Seizures, Seizure Disorder
Recruiting
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Convulsion, Non-Epileptic
RecruitingPhase 1/2
Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial
Non Epileptic Seizures
Active, not recruitingObservational study
Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures
Epilepsy, Psychogenic Non-epileptic Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Neurofeedback in people with Psychogenic Seizure and Epilepsy, Temporal Lobe, run by ETH Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Electrophysiological data, i.e., EEG power in alpha band (time frame: Before and immediately after neurofeedback). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.