Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents (NFB@HOME)

  • STATUS
    Recruiting
  • days left to enroll
    77
  • participants needed
    48
  • sponsor
    University Hospital, Geneva
Updated on 23 May 2022
hyperactivity

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.

Details
Condition Attention Deficit Disorder With Hyperactivity
Treatment Control, Neurofeedback
Clinical Study IdentifierNCT04408521
SponsorUniversity Hospital, Geneva
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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