Effects of EEG- Microstate Neurofeedback on Attention and Impulsivity in Adult Attention-deficit/Hyperactivity Disorder (ADHD) and Neurotypical Controls
NCT ID: NCT05582928
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-09-19
2025-06-30
Brief Summary
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Detailed Description
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In the light of recent findings on EEG microstate and the ADHD population, the hypothesis is that microstate D could be a potential functional biomarker of ADHD. To test it, the proposal is to modulate this microstate using a neurofeedback training protocol directly targeting microstate parameters. According to the main hypothesis, changes in microstate parameters should be correlated with change in attentional and impulsive behaviour. To answer this question, a two-session study was designed, where participants will perform a continuous performance task (CPT) before and after 30 minutes of microstate-based neurofeedback training. During one of the sessions participants will be trained to upregulate microstate parameters, while during the other one, they will be trained to downregulate the same parameters. Intra- and across-section statistical contrasts, both in terms of brain activity changes and behavioural performance, should provide evidence to evaluate the impact of microstate changes relative to behaviour. In addition, and according to a large number of studies on ERP components in ADHD patients the recording of event related potentials (ERPs) during the behavioural task could help us understand the neurophysiological changes linked to attention and impulsivity measures.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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healthy population group
The experimental design includes three sessions:
* session 1 will be used to evaluate diagnostic using different targeted questionnaires.
* sessions 2 and 3 will be decomposed into 3 consecutives parts:
1. Pre evaluation
2. Neurofeedback
3. Post evaluation
Neurofeedback
Neurofeedback training during which participant will be asked to change the size of a bar using different strategies to vary the parameters of its current brain's states (neurofeedback training) computed on the realtime EEG signals.
ADHD population group
The experimental design includes three sessions:
* session 1 will be used to evaluate diagnostic using different targeted questionnaires.
* sessions 2 and 3 will be decomposed into 3 consecutives parts:
1. Pre evaluation
2. Neurofeedback
3. Post evaluation
Neurofeedback
Neurofeedback training during which participant will be asked to change the size of a bar using different strategies to vary the parameters of its current brain's states (neurofeedback training) computed on the realtime EEG signals.
Interventions
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Neurofeedback
Neurofeedback training during which participant will be asked to change the size of a bar using different strategies to vary the parameters of its current brain's states (neurofeedback training) computed on the realtime EEG signals.
Eligibility Criteria
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Inclusion Criteria
* Gender: male and female
* Health: general good health and normal or corrected-to-normal visual acuity
* Patients clinically able to stop the following psychotropic medications for 48h: psychostimulants, benzodiazepines
* Having provided written informed written consent
A subject will not be eligible if any of the following criteria apply:
* Past or current history of a clinically significant central nervous system disorder, including structural brain abnormalities; cerebrovascular disease; history of other neurological disease, epilepsy, stroke or head trauma (defined as loss of consciousness \> 5 min or requiring hospitalization)
* Impaired vision (normal or corrected acuity below 20/40)
* Medical illness (e.g., cardiovascular disease, renal failure, hepatic dysfunction)
* Comorbidities with current psychiatric disorders (bipolar disorder, borderline personality disorder, major depressive disorder, anxiety disorder) including substance use disorder as defined by the DIGS.
HEALTHY POPULATION GROUP
A subject will be eligible if all of the following criteria apply:
* Age: between 18-50 years
* Gender: male and female
* Health: general good health and normal or corrected-to-normal visual acuity
* Having provided written informed written consent
A subject will not be eligible if any of the following criteria apply:
* Past or current history of ADHD
* Past or current history of main psychiatric disorders (bipolar disorder, borderline personality disorder, major depressive disorder, anxiety disorder), including substance use disorder as defined by the DIGS.
* Past or current history of a clinically significant central nervous system disorder, including structural brain abnormalities; cerebrovascular disease; history of other neurological disease, including epilepsy, stroke or head trauma (defined as loss of consciousness \> 5 min or requiring hospitalization)
* Impaired vision (normal or corrected acuity below 20/40)
* Medical illness (e.g., cardiovascular disease, renal failure, hepatic dysfunction)
18 Years
50 Years
ALL
Yes
Sponsors
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University of Geneva, Switzerland
OTHER
University Hospital, Geneva
OTHER
Nader Perroud
OTHER
Responsible Party
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Nader Perroud
Professor
Principal Investigators
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Nader Perroud, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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TRE Unit (Trouble de la Régulation Emotionnelle) Department of psychiatry, HUG
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2022-00848
Identifier Type: -
Identifier Source: org_study_id