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Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04408521
Acronym
NFB@HOME
Enrollment
5
Registered
2020-05-29
Start date
2020-11-02
Completion date
2026-04-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Electroencephalography, Alpha Rhythm, Attention, Impulsive Behavior, Neurofeedback

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.

Interventions

OTHERNEUROFEEDBACK

EEG recording during alpha-related TV viewing

OTHERCONTROL

EEG recording during passive TV viewing

Sponsors

University of Geneva, Switzerland
CollaboratorOTHER
University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in assessor-evaluated clinical ADHD statusChange between day 10 pre-intervention and day 10 post-interventionChange in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)
Change in self-reported clinical ADHD statusChange between day 10 pre-intervention and day 10 post-interventionChange in adult ADHD Self-Report Scale (ASRS) scoring (min = 0, max = 72, higher score = worse outcome)
Change in Alpha Spectral PowerChange between day 2 pre-intervention and day 2 post-interventionAbsolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)
Change in reaction time at the Continuous Performance Task (CPT)Change between day 2 pre-intervention and day 2 post-interventionReaction time and reaction time variability (milliseconds)
Change in error rates at the CPTChange between day 2 pre-intervention and day 2 post-interventionNumber of omission and commission errors

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026