Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

Attention Deficit Disorder With Hyperactivity Clinical Trial

— NFB@HOME  

Official title:

Effect of Long-lasting EEG-Neurofeedback on Attention Control and Impulsivity in Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04408521
• Other study ID #: 2017-01029
• Secondary ID: SNCTP000002260
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: April 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Other:
• NEUROFEEDBACK
EEG recording during alpha-related TV viewing
• CONTROL
EEG recording during passive TV viewing

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

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. — View 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 — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in assessor-evaluated clinical ADHD status	Change in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)	Change between day 10 pre-intervention and day 10 post-intervention
Primary	Change in self-reported clinical ADHD status	Change in adult ADHD Self-Report Scale (ASRS) scoring (min = 0, max = 72, higher score = worse outcome)	Change between day 10 pre-intervention and day 10 post-intervention
Primary	Change in Alpha Spectral Power	Absolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)	Change between day 2 pre-intervention and day 2 post-intervention
Primary	Change in reaction time at the Continuous Performance Task (CPT)	Reaction time and reaction time variability (milliseconds)	Change between day 2 pre-intervention and day 2 post-intervention
Primary	Change in error rates at the CPT	Number of omission and commission errors	Change between day 2 pre-intervention and day 2 post-intervention