NCT05582928

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

October 10, 2022

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • Change in microstate coverage during rest

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

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

Secondary Outcomes (2)

  • Correlations between EEG microstate time coverage (%) and task performance: error rates (%) and reaction time.

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

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

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

Study Arms (2)

healthy population group

EXPERIMENTAL

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

Device: Neurofeedback

ADHD population group

EXPERIMENTAL

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

Device: Neurofeedback

Interventions

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 grouphealthy population group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

TRE Unit (Trouble de la Régulation Emotionnelle) Department of psychiatry, HUG

Geneva, 1201, Switzerland

RECRUITING

Related Publications (28)

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    PMID: 23086616BACKGROUND
  • 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.

    PMID: 23099283BACKGROUND
  • 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.

    PMID: 19715181BACKGROUND
  • 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.

    PMID: 30902640BACKGROUND
  • 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.

    PMID: 29937325BACKGROUND
  • 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.

    PMID: 19711183BACKGROUND
  • 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.

    PMID: 20188188BACKGROUND
  • 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.

    PMID: 19116846BACKGROUND
  • 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.

    PMID: 30498872BACKGROUND
  • 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.

    PMID: 28938855BACKGROUND
  • 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.

    PMID: 16945915BACKGROUND
  • 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.

    PMID: 34153722BACKGROUND
  • 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.

    PMID: 31911342BACKGROUND
  • 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.

    PMID: 26582260BACKGROUND
  • 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.

    PMID: 32559806BACKGROUND
  • Ferat V, Arns M, Deiber MP, Hasler R, Perroud N, Michel CM, Ros T. Electroencephalographic Microstates as Novel Functional Biomarkers for Adult Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Aug;7(8):814-823. doi: 10.1016/j.bpsc.2021.11.006. Epub 2021 Nov 22.

    PMID: 34823049BACKGROUND
  • Hammer BU, Colbert AP, Brown KA, Ilioi EC. Neurofeedback for insomnia: a pilot study of Z-score SMR and individualized protocols. Appl Psychophysiol Biofeedback. 2011 Dec;36(4):251-64. doi: 10.1007/s10484-011-9165-y.

    PMID: 21789650BACKGROUND
  • Heinrich H, Gevensleben H, Strehl U. Annotation: neurofeedback - train your brain to train behaviour. J Child Psychol Psychiatry. 2007 Jan;48(1):3-16. doi: 10.1111/j.1469-7610.2006.01665.x.

    PMID: 17244266BACKGROUND
  • Horrell T, El-Baz A, Baruth J, Tasman A, Sokhadze G, Stewart C, Sokhadze E. Neurofeedback Effects on Evoked and Induced EEG Gamma Band Reactivity to Drug-related Cues in Cocaine Addiction. J Neurother. 2010 Jul;14(3):195-216. doi: 10.1080/10874208.2010.501498.

    PMID: 20976131BACKGROUND
  • Katayama H, Gianotti LR, Isotani T, Faber PL, Sasada K, Kinoshita T, Lehmann D. Classes of multichannel EEG microstates in light and deep hypnotic conditions. Brain Topogr. 2007 Fall;20(1):7-14. doi: 10.1007/s10548-007-0024-3. Epub 2007 Jun 21.

    PMID: 17587166BACKGROUND
  • Kropotov JD, Grin-Yatsenko VA, Ponomarev VA, Chutko LS, Yakovenko EA, Nikishena IS. ERPs correlates of EEG relative beta training in ADHD children. Int J Psychophysiol. 2005 Jan;55(1):23-34. doi: 10.1016/j.ijpsycho.2004.05.011.

    PMID: 15598513BACKGROUND
  • Krylova M, Alizadeh S, Izyurov I, Teckentrup V, Chang C, van der Meer J, Erb M, Kroemer N, Koenig T, Walter M, Jamalabadi H. Evidence for modulation of EEG microstate sequence by vigilance level. Neuroimage. 2021 Jan 1;224:117393. doi: 10.1016/j.neuroimage.2020.117393. Epub 2020 Sep 21.

    PMID: 32971266BACKGROUND
  • Mantini D, Perrucci MG, Del Gratta C, Romani GL, Corbetta M. Electrophysiological signatures of resting state networks in the human brain. Proc Natl Acad Sci U S A. 2007 Aug 7;104(32):13170-5. doi: 10.1073/pnas.0700668104. Epub 2007 Aug 1.

    PMID: 17670949BACKGROUND
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    PMID: 29196270BACKGROUND
  • Mottaz A, Solca M, Magnin C, Corbet T, Schnider A, Guggisberg AG. Neurofeedback training of alpha-band coherence enhances motor performance. Clin Neurophysiol. 2015 Sep;126(9):1754-60. doi: 10.1016/j.clinph.2014.11.023. Epub 2014 Dec 6.

    PMID: 25540133BACKGROUND
  • Walker JE, Kozlowski GP. Neurofeedback treatment of epilepsy. Child Adolesc Psychiatr Clin N Am. 2005 Jan;14(1):163-76, viii. doi: 10.1016/j.chc.2004.07.009.

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  • Walker JE. Using QEEG-guided neurofeedback for epilepsy versus standardized protocols: enhanced effectiveness? Appl Psychophysiol Biofeedback. 2010 Mar;35(1):29-30. doi: 10.1007/s10484-009-9123-0.

    PMID: 20012556BACKGROUND
  • Zioga I, Hassan R, Luft CDB. Success, but not failure feedback guides learning during neurofeedback: An ERP study. Neuroimage. 2019 Oct 15;200:26-37. doi: 10.1016/j.neuroimage.2019.06.002. Epub 2019 Jun 12.

    PMID: 31200067BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Nader Perroud, Professor

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nader Perroud, Professor

CONTACT

Marie-Pierre Deiber, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 17, 2022

Study Start

September 19, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations