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ADHDADHDmicroNFBNCT05582928

Effects of EEG- Microstate Neurofeedback on Attention and Impulsivity in Adult Attention-deficit/Hyperactivity Disorder (ADHD) and Neurotypical Controls

A study testing Neurofeedback in people with ADHD and Healthy, run by Nader Perroud at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

EEG neurofeedback (NFB) may represent a new therapeutic opportunity for ADHD, a neuropsychiatric disorder characterized by attentional deficits and high impulsivity. Recent research of the Geneva group has demonstrated the ability of ADHD patients to control specific features of their EEG (notably alpha… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
ADHD, Healthy
What is being tested?
Neurofeedback
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSwitzerland
Study dates
19 Sep 2022to Jun 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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

ADHD POPULATION GROUP

A subject will be eligible if all 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
  • 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)

Trial locations and contacts

1 site in 1 country.

Nader Perroud, Professor contact

+41 22 305 45 11

nader.perroud@hcuge.ch

Marie-Pierre Deiber, PhD contact

+41 22 379 11 25

marie-pierre.deiber@hcuge.ch

Switzerland1 site, 1 recruiting
  • TRE Unit (Trouble de la Régulation Emotionnelle) Department of psychiatry, HUG

    Geneva, 1201

    Nader Perroud, Professor, +41 (0)22 305 45 11, nader.perroud@hcuge.ch

    Roland Hasler, PhD, +41 (0)22 305 45 11, roland.hasler@hcuge.ch

    Recruiting

Other trials in Switzerland

About this study

EEG neurofeedback (NFB) may represent a new therapeutic opportunity for ADHD, a neuropsychiatric disorder characterized by attentional deficits and high impulsivity. Recent research of the Geneva group has demonstrated the ability of ADHD patients to control specific features of their EEG (notably alpha desynchronization) and that this control was associated with reduced impulsivity. In addition, alterations in EEG brain microstates (i.e., recurrent stable periods of short duration) have been described in adult ADHD patients, potentially representing a biomarker of the disorder. The present study aims to use neurofeedback to manipulate EEG microstates in ADHD patients and healthy controls, in order to observe the effects on neurophysiological, clinical and behavioural parameters.

Read the detailed description

Neurofeedback (NFB) is a broadly used method that enables individuals to self-regulate one or more neurophysiological parameters. In the case of electroencephalography (EEG) the parameters most often used so far are slow cortical potentials (SCPs), coherence training and frequency training. Protocols based on these measures have been applied to many clinical populations exhibiting abnormal EEG patterns including schizophrenia, insomnia, dyslexia, drug addiction, autistic spectrum disorder and attention deficit/hyperactivity disorder (ADHD). Today, the most widely used neurofeedback protocol for the ADHD population is based on the theta/beta ratio (TBR). However more recent studies have failed to replicate this finding of elevated TBR as a diagnostic feature in ADHD, which was also confirmed in a meta-analysis. These divergent results motivate the need for research to explore new markers to diagnose and treat ADHD. In a recent study, Férat and colleagues proposed EEG microstate analysis as a new framework to study ADHD. Microstate analysis models spontaneous EEG as a sequence of states defined by recurring appearance of a given distribution of scalp potentials. The authors observed a significantly increased contribution of one specific state commonly referred to microstate D in the ADHD population compared to healthy subjects. This state is often associated with attentional functions and brain regions in the dorsal attention networks are involved . It would therefore be interesting to study the causal link between this microstate and attention by manipulating this biomarker with neurofeedback. In this context, a recent study by Hernandez and colleagues has already demonstrated that healthy participants were able to control such brain microstates by neurofeedback. The aim of the present study is to test whether patients with ADHD are also capable of self-regulating their microstate dynamics.

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
ADHD, Healthy
Being tested
Neurofeedback
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurofeedbackDevice

    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.

Study groups in NCT05582928
Study groupRoleWhat they receive
healthy population groupExperimentalThe 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
Receives: Device: Neurofeedback
ADHD population groupExperimentalThe 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
Receives: Device: Neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in microstate coverage during training

    Difference in EEG microstate time coverage (%) between training and rest periods for each session (session 2, session 3) independently.

    Measured: Change within session at week 1 (session 2) and week 2 (session 2)

  2. Change in microstate coverage during rest

    Difference in EEG microstate time coverage (%) between rest periods for each session (session 2, session 3) independently.

    Measured: Change within session week 1 (session 2) and week 2 (session 2)

Secondary outcomes (2)
  1. Correlations between EEG microstate time coverage (%) and task performance: error rates (%) and reaction time.

    Measured: Within session at week 1 (session 2) and week 2 (session 2)

  2. Change in EEG Event Related potentiels before and after neurofeedback training.

    For each condition (Go/NoGo) we will investigate differences in Global map dissimilarity (GMD), amplitude and microstate segmentation between pre and post neurofeedback training tasks.

    Measured: Within session at week 1 (session 2) and week 2 (session 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2022
  2. Study start19 Sep 2022
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05582928
Sponsor's protocol ID
2022-00848
Acronym
ADHDmicroNFB
Status last verified
Nov 2023
First submitted
10 Oct 2022
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Arns M, Conners CK, Kraemer HC. A decade of EEG Theta/Beta Ratio Research in ADHD: a meta-analysis. J Atten Disord. 2013 Jul;17(5):374-83. doi: 10.1177/1087054712460087. Epub 2012 Oct 19.

    PubMed 23086616
  • Arns M, Kenemans JL. Neurofeedback in ADHD and insomnia: vigilance stabilization through sleep spindles and circadian networks. Neurosci Biobehav Rev. 2014 Jul;44:183-94. doi: 10.1016/j.neubiorev.2012.10.006. Epub 2012 Oct 23.

    PubMed 23099283
  • Arns M, de Ridder S, Strehl U, Breteler M, Coenen A. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci. 2009 Jul;40(3):180-9. doi: 10.1177/155005940904000311.

    PubMed 19715181
  • Brechet L, Brunet D, Birot G, Gruetter R, Michel CM, Jorge J. Capturing the spatiotemporal dynamics of self-generated, task-initiated thoughts with EEG and fMRI. Neuroimage. 2019 Jul 1;194:82-92. doi: 10.1016/j.neuroimage.2019.03.029. Epub 2019 Mar 19.

    PubMed 30902640
  • Arns M, Vollebregt MA, Palmer D, Spooner C, Gordon E, Kohn M, Clarke S, Elliott GR, Buitelaar JK. Electroencephalographic biomarkers as predictors of methylphenidate response in attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2018 Aug;28(8):881-891. doi: 10.1016/j.euroneuro.2018.06.002. Epub 2018 Jun 22.

    PubMed 29937325
  • Breteler MH, Arns M, Peters S, Giepmans I, Verhoeven L. Improvements in spelling after QEEG-based neurofeedback in dyslexia: a randomized controlled treatment study. Appl Psychophysiol Biofeedback. 2010 Mar;35(1):5-11. doi: 10.1007/s10484-009-9105-2. Epub 2009 Aug 27.

    PubMed 19711183
  • Britz J, Van De Ville D, Michel CM. BOLD correlates of EEG topography reveal rapid resting-state network dynamics. Neuroimage. 2010 Oct 1;52(4):1162-70. doi: 10.1016/j.neuroimage.2010.02.052. Epub 2010 Feb 24.

    PubMed 20188188
  • Cannon R, Congedo M, Lubar J, Hutchens T. Differentiating a network of executive attention: LORETA neurofeedback in anterior cingulate and dorsolateral prefrontal cortices. Int J Neurosci. 2009;119(3):404-41. doi: 10.1080/00207450802480325.

    PubMed 19116846
  • Comsa IM, Bekinschtein TA, Chennu S. Transient Topographical Dynamics of the Electroencephalogram Predict Brain Connectivity and Behavioural Responsiveness During Drowsiness. Brain Topogr. 2019 Mar;32(2):315-331. doi: 10.1007/s10548-018-0689-9. Epub 2018 Nov 29.

    PubMed 30498872
  • Custo A, Van De Ville D, Wells WM, Tomescu MI, Brunet D, Michel CM. Electroencephalographic Resting-State Networks: Source Localization of Microstates. Brain Connect. 2017 Dec;7(10):671-682. doi: 10.1089/brain.2016.0476. Epub 2017 Nov 17.

    PubMed 28938855
  • Damoiseaux JS, Rombouts SA, Barkhof F, Scheltens P, Stam CJ, Smith SM, Beckmann CF. Consistent resting-state networks across healthy subjects. Proc Natl Acad Sci U S A. 2006 Sep 12;103(37):13848-53. doi: 10.1073/pnas.0601417103. Epub 2006 Aug 31.

    PubMed 16945915
  • Deiber MP, Ammann C, Hasler R, Colin J, Perroud N, Ros T. Electrophysiological correlates of improved executive function following EEG neurofeedback in adult attention deficit hyperactivity disorder. Clin Neurophysiol. 2021 Aug;132(8):1937-1946. doi: 10.1016/j.clinph.2021.05.017. Epub 2021 Jun 11.

    PubMed 34153722
  • Deiber MP, Hasler R, Colin J, Dayer A, Aubry JM, Baggio S, Perroud N, Ros T. Linking alpha oscillations, attention and inhibitory control in adult ADHD with EEG neurofeedback. Neuroimage Clin. 2020;25:102145. doi: 10.1016/j.nicl.2019.102145. Epub 2019 Dec 24.

    PubMed 31911342
  • Diaz Hernandez L, Rieger K, Baenninger A, Brandeis D, Koenig T. Towards Using Microstate-Neurofeedback for the Treatment of Psychotic Symptoms in Schizophrenia. A Feasibility Study in Healthy Participants. Brain Topogr. 2016 Mar;29(2):308-21. doi: 10.1007/s10548-015-0460-4. Epub 2015 Nov 19.

    PubMed 26582260
  • Drechsler R, Brem S, Brandeis D, Grunblatt E, Berger G, Walitza S. ADHD: Current Concepts and Treatments in Children and Adolescents. Neuropediatrics. 2020 Oct;51(5):315-335. doi: 10.1055/s-0040-1701658. Epub 2020 Jun 19.

    PubMed 32559806

Questions about this trial

What is this clinical trial studying?

A study testing Neurofeedback in people with ADHD and Healthy, run by Nader Perroud 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?

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 29 Nov 2023. 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. 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?

Contact Nader Perroud, Professor (+41 22 305 45 11, nader.perroud@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in microstate coverage during training (time frame: Change within session at week 1 (session 2) and week 2 (session 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05582928, which also lists 28 linked publications.

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 29 Nov 2023.

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