Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents
NCT ID: NCT04408521
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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ACTIVE_NOT_RECRUITING
NA
5 participants
INTERVENTIONAL
2020-11-02
2026-04-30
Brief Summary
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A short- (single-session) and a long-term (multi-session) experimental design will be used to collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL groups. Each participant will undergo individual at home sessions of 45-minute video-replay of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5 sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm will be reflected in the dynamically varying opacity of the video-replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively. In the CONTROL group, the recording will be passive without real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home training, each participant will have two visits in the lab: (1) complete clinical and neuropsychological evaluation and (2) EEG session including resting state and task-related EEG before and after a short NFB intervention (30 minutes). For the CONTROL group participants, the latter will be replaced by a sham intervention utilizing non-contingent feedback.
Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power and (ii) the degree of normalization will be a dimensional predictor of individual improvement in behavioral and clinical measures of executive function, impulsivity and inattention. These results should lay the foundation for building neurocognitive treatments, by harnessing neuroplasticity mechanisms intrinsic to the brain.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NEUROFEEDBACK
Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. Self-regulation of alpha rhythm is reflected in the dynamically varying opacity of the video replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively.
NEUROFEEDBACK
EEG recording during alpha-related TV viewing
CONTROL
Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. The recording is passive without real-time EEG neurofeedback (i.e. constant brightness and volume).
CONTROL
EEG recording during passive TV viewing
Interventions
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NEUROFEEDBACK
EEG recording during alpha-related TV viewing
CONTROL
EEG recording during passive TV viewing
Eligibility Criteria
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Inclusion Criteria
* Currently stabilized (euthymic)
* General good health
* Normal or corrected-to normal visual acuity
Exclusion Criteria
* PTSD
* Borderline Personality Disorder
* Substance Use Disorder
* Structural Brain Abnormalities
* Cerebrovascular Disease
* Epilepsy
* Stroke
* Head Trauma
* Cardiovascular Disease
* Renal Failure
* Hepatic Dysfunction
* Impaired visual acuity
18 Years
50 Years
ALL
No
Sponsors
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University of Geneva, Switzerland
OTHER
University Hospital, Geneva
OTHER
Responsible Party
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Nader Perroud
MD, Associate Professor
Principal Investigators
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Alexandre Dayer, MD, PhD
Role: STUDY_DIRECTOR
University of Geneva & University Hospitals of Geneva
Locations
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University Hospitals of Geneva
Geneva, , Switzerland
Countries
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References
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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.
Ergenoglu T, Demiralp T, Bayraktaroglu Z, Ergen M, Beydagi H, Uresin Y. Alpha rhythm of the EEG modulates visual detection performance in humans. Brain Res Cogn Brain Res. 2004 Aug;20(3):376-83. doi: 10.1016/j.cogbrainres.2004.03.009.
Macdonald JS, Mathan S, Yeung N. Trial-by-Trial Variations in Subjective Attentional State are Reflected in Ongoing Prestimulus EEG Alpha Oscillations. Front Psychol. 2011 May 10;2:82. doi: 10.3389/fpsyg.2011.00082. eCollection 2011.
Micoulaud-Franchi JA, Geoffroy PA, Fond G, Lopez R, Bioulac S, Philip P. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci. 2014 Nov 13;8:906. doi: 10.3389/fnhum.2014.00906. eCollection 2014.
Heidbreder R. ADHD symptomatology is best conceptualized as a spectrum: a dimensional versus unitary approach to diagnosis. Atten Defic Hyperact Disord. 2015 Dec;7(4):249-69. doi: 10.1007/s12402-015-0171-4. Epub 2015 May 10.
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.
Other Identifiers
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SNCTP000002260
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-01029
Identifier Type: -
Identifier Source: org_study_id