Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

Not Applicable

Active, not recruiting

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Other: NEUROFEEDBACK; Other: CONTROL

• Registration Number: NCT04408521
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-29
• Study Start: 2020-11-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEUROFEEDBACK	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.
CONTROL	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland