Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

NCT04408521 | Active Not Recruiting

• 2 other identifiers: 2017-01029SNCTP000002260
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Electroencephalography; Alpha Rhythm; Attention; Impulsive Behavior; Neurofeedback

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Change in error rates at the CPT

  Number of omission and commission errors

  Change between day 2 pre-intervention and day 2 post-intervention

Study Arms (2)

NEUROFEEDBACK

EXPERIMENTAL

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.

Other: NEUROFEEDBACK

CONTROL

PLACEBO COMPARATOR

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).

Other: CONTROL

Interventions

NEUROFEEDBACK OTHER

EEG recording during alpha-related TV viewing

NEUROFEEDBACK

CONTROL OTHER

EEG recording during passive TV viewing

CONTROL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Geneva, Switzerland: collaborator

Study Sites (1)

University Hospitals of Geneva

Geneva, 1201, Switzerland

Location

Related 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.

  PMID: 19715181 BACKGROUND

• 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.

  PMID: 15268915 BACKGROUND

• 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.

  PMID: 21687452 BACKGROUND

• 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.

  PMID: 25431555 BACKGROUND

• 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.

  PMID: 25957598 BACKGROUND

• 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.

  PMID: 31911342 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Impulsive Behavior

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Alexandre Dayer, MD, PhD

  University of Geneva & University Hospitals of Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 29, 2020
• Study Start: November 2, 2020
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)