Clinical trial NCT04408521: Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents
Official title: Effect of Long-lasting EEG-Neurofeedback on Attention Control and Impulsivity in Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Electroencephalography
Alpha Rhythm
Attention
Impulsive Behavior
Neurofeedback
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2020-05-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback (NFB), may represent a new therapeutic opportunity for patients with Attentional Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and inhibitory control. In this context, the investigators have focused on an attention-enhancing form of NFB based on the EEG alpha rhythm, known to influence sensory detection and attention. In light of recent evidence showing that both attention and impulsivity can be modified with a single-session of alpha-NFB, the objective is to determine whether these effects stabilize in the long-term, after multiple, daily sessions of training at home.

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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ADHD
* Currently stabilized (euthymic)
* General good health
* Normal or corrected-to normal visual acuity

Exclusion Criteria:

* Mood Disorders
* 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

Primary outcomes:
measure: Change in assessor-evaluated clinical ADHD status
timeFrame: Change between day 10 pre-intervention and day 10 post-intervention
measure: Change in self-reported clinical ADHD status
timeFrame: Change between day 10 pre-intervention and day 10 post-intervention
measure: Change in Alpha Spectral Power
timeFrame: Change between day 2 pre-intervention and day 2 post-intervention
measure: Change in reaction time at the Continuous Performance Task (CPT)
timeFrame: Change between day 2 pre-intervention and day 2 post-intervention
measure: Change in error rates at the CPT
timeFrame: Change between day 2 pre-intervention and day 2 post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University of Geneva & University Hospitals of Geneva
name: Alexandre Dayer, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.