Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-01 @ 3:13 AM
Study NCT ID:
NCT05214833
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000091323', 'term': 'Psychogenic Nonepileptic Seizures'}, {'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}], 'ancestors': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Two arms will be investigated. The first one will receive real neurofeedback. The second one will receive sham neurofeedback (comparator).\n\nDuring sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age in years', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable'}, {'measure': 'Sex (male/female)', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable'}, {'measure': 'Years of education', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable'}, {'measure': 'Medication status', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable, list of drugs currently in use by the participant'}, {'measure': 'Anxiety', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable assessed with the State-Trait Anxiety Inventory (STAI). Minimum value (20) = no anxiety. Maximum value (80) = high anxiety.'}, {'measure': 'Mood', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable assessed with a visual analog scale. Minimum value (0) = bad mood. Maximum value (100) = good mood.'}, {'measure': 'Sleep habits', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value (0) = good sleep quality. Maximum value (20) = poor sleep quality.'}, {'measure': 'Daily rate of cigarettes', 'timeFrame': 'Before neurofeedback', 'description': 'Baseline variable assessed in number of cigarettes/day'}], 'primaryOutcomes': [{'measure': 'Change in Electrophysiological data, i.e., EEG power in alpha band', 'timeFrame': 'Before and immediately after neurofeedback', 'description': 'Brain activity'}, {'measure': 'Change in Electrophysiological data, i.e., EEG power in theta band', 'timeFrame': 'Before and immediately after neurofeedback', 'description': 'Brain activity'}, {'measure': 'Change in Electrophysiological data, i.e., EEG power in gamma band', 'timeFrame': 'Before and immediately after neurofeedback', 'description': 'Brain activity'}, {'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', 'description': 'Behavioural performance in response to manipulation of the Sense of Agency (SoA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sense of agency'], 'conditions': ['Psychogenic Seizure', 'Epilepsy, Temporal Lobe', 'Health, Subjective']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (all):\n\n* Aged \\> 18 years old\n* Normal or corrected-to-normal visual acuity\n* Willing to participate in the study (by signing the informed consent form)\n* Neither caffein, nor alcohol intake 48 hours prior to the experiment\n* Regular intake of drugs (except oral contraceptives in women)\n* Employed by, or in a dependent relationship with, the sponsor and / or the investigator(s)\n* Sufficient knowledge of German or English to understand study documents and instructions.\n\nInclusion Criteria (patients):\n\n* A diagnosis of temporal epilepsy (TE), documented via video EEG. OR\n* 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.\n\nExclusion Criteria (all):\n\n* Past surgery in the brain\n* History of alcohol or drug abuse\n* Incompatibility with EEG recordings, e.g., inability to stay seated for 90 minutes.'}, 'identificationModule': {'nctId': 'NCT05214833', 'acronym': 'NF-Agency', 'briefTitle': 'Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback', 'organization': {'class': 'OTHER', 'fullName': 'ETH Zurich'}, 'officialTitle': 'Self-modulation of the Sense of Agency by Means of Real-time Neurofeedback', 'orgStudyIdInfo': {'id': '2021-02093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real neurofeedback', 'description': 'The first arm will receive real neurofeedback.', 'interventionNames': ['Behavioral: Real Neurofeedback']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham neurofeedback', 'description': 'The second arm will receive sham neurofeedback.', 'interventionNames': ['Behavioral: Sham Neurofeedback']}], 'interventions': [{'name': 'Real Neurofeedback', 'type': 'BEHAVIORAL', 'description': 'During neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants.', 'armGroupLabels': ['Real neurofeedback']}, {'name': 'Sham Neurofeedback', 'type': 'BEHAVIORAL', 'description': "During sham neurofeedback, a signal which resembles the participant's brain activity is used instead of the actual brain activity.", 'armGroupLabels': ['Sham neurofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8057', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Giuseppe A Zito, PhD', 'role': 'CONTACT', 'email': 'zito.giuseppe.angelo@gmail.com', 'phone': '+41766691816'}], 'facility': 'ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ETH Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss Epilepsy Centre - Klinik Lengg', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuseppe Angelo Zito', 'investigatorAffiliation': 'ETH Zurich'}}}}