Effects of EEG- Microstate Neurofeedback on Attention and Impulsivity in Adult Attention-deficit/Hyperactivity Disorder (ADHD) and Neurotypical Controls (ADHDmicroNFB)

November 28, 2023 updated by: Nader Perroud
EEG neurofeedback (NFB) may represent a new therapeutic opportunity for ADHD, a neuropsychiatric disorder characterized by attentional deficits and high impulsivity. Recent research of the Geneva group has demonstrated the ability of ADHD patients to control specific features of their EEG (notably alpha desynchronization) and that this control was associated with reduced impulsivity. In addition, alterations in EEG brain microstates (i.e., recurrent stable periods of short duration) have been described in adult ADHD patients, potentially representing a biomarker of the disorder. The present study aims to use neurofeedback to manipulate EEG microstates in ADHD patients and healthy controls, in order to observe the effects on neurophysiological, clinical and behavioural parameters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Neurofeedback (NFB) is a broadly used method that enables individuals to self-regulate one or more neurophysiological parameters. In the case of electroencephalography (EEG) the parameters most often used so far are slow cortical potentials (SCPs), coherence training and frequency training. Protocols based on these measures have been applied to many clinical populations exhibiting abnormal EEG patterns including schizophrenia, insomnia, dyslexia, drug addiction, autistic spectrum disorder and attention deficit/hyperactivity disorder (ADHD). Today, the most widely used neurofeedback protocol for the ADHD population is based on the theta/beta ratio (TBR). However more recent studies have failed to replicate this finding of elevated TBR as a diagnostic feature in ADHD, which was also confirmed in a meta-analysis. These divergent results motivate the need for research to explore new markers to diagnose and treat ADHD. In a recent study, Férat and colleagues proposed EEG microstate analysis as a new framework to study ADHD. Microstate analysis models spontaneous EEG as a sequence of states defined by recurring appearance of a given distribution of scalp potentials. The authors observed a significantly increased contribution of one specific state commonly referred to microstate D in the ADHD population compared to healthy subjects. This state is often associated with attentional functions and brain regions in the dorsal attention networks are involved . It would therefore be interesting to study the causal link between this microstate and attention by manipulating this biomarker with neurofeedback. In this context, a recent study by Hernandez and colleagues has already demonstrated that healthy participants were able to control such brain microstates by neurofeedback. The aim of the present study is to test whether patients with ADHD are also capable of self-regulating their microstate dynamics.

In the light of recent findings on EEG microstate and the ADHD population, the hypothesis is that microstate D could be a potential functional biomarker of ADHD. To test it, the proposal is to modulate this microstate using a neurofeedback training protocol directly targeting microstate parameters. According to the main hypothesis, changes in microstate parameters should be correlated with change in attentional and impulsive behaviour. To answer this question, a two-session study was designed, where participants will perform a continuous performance task (CPT) before and after 30 minutes of microstate-based neurofeedback training. During one of the sessions participants will be trained to upregulate microstate parameters, while during the other one, they will be trained to downregulate the same parameters. Intra- and across-section statistical contrasts, both in terms of brain activity changes and behavioural performance, should provide evidence to evaluate the impact of microstate changes relative to behaviour. In addition, and according to a large number of studies on ERP components in ADHD patients the recording of event related potentials (ERPs) during the behavioural task could help us understand the neurophysiological changes linked to attention and impulsivity measures.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1201
        • Recruiting
        • TRE Unit (Trouble de la Régulation Emotionnelle) Department of psychiatry, HUG
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Description

ADHD POPULATION GROUP

A subject will be eligible if all the following criteria apply:

  • Age: between 18-50 years
  • Gender: male and female
  • Health: general good health and normal or corrected-to-normal visual acuity
  • Patients clinically able to stop the following psychotropic medications for 48h: psychostimulants, benzodiazepines
  • Having provided written informed written consent

A subject will not be eligible if any of the following criteria apply:

  • Past or current history of a clinically significant central nervous system disorder, including structural brain abnormalities; cerebrovascular disease; history of other neurological disease, epilepsy, stroke or head trauma (defined as loss of consciousness > 5 min or requiring hospitalization)
  • Impaired vision (normal or corrected acuity below 20/40)
  • Medical illness (e.g., cardiovascular disease, renal failure, hepatic dysfunction)
  • Comorbidities with current psychiatric disorders (bipolar disorder, borderline personality disorder, major depressive disorder, anxiety disorder) including substance use disorder as defined by the DIGS.

HEALTHY POPULATION GROUP

A subject will be eligible if all of the following criteria apply:

  • Age: between 18-50 years
  • Gender: male and female
  • Health: general good health and normal or corrected-to-normal visual acuity
  • Having provided written informed written consent

A subject will not be eligible if any of the following criteria apply:

  • Past or current history of ADHD
  • Past or current history of main psychiatric disorders (bipolar disorder, borderline personality disorder, major depressive disorder, anxiety disorder), including substance use disorder as defined by the DIGS.
  • Past or current history of a clinically significant central nervous system disorder, including structural brain abnormalities; cerebrovascular disease; history of other neurological disease, including epilepsy, stroke or head trauma (defined as loss of consciousness > 5 min or requiring hospitalization)
  • Impaired vision (normal or corrected acuity below 20/40)
  • Medical illness (e.g., cardiovascular disease, renal failure, hepatic dysfunction)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy population group

The experimental design includes three sessions:

  • session 1 will be used to evaluate diagnostic using different targeted questionnaires.

  • sessions 2 and 3 will be decomposed into 3 consecutives parts:

    1. Pre evaluation
    2. Neurofeedback
    3. Post evaluation
Device: Neurofeedback
Neurofeedback training during which participant will be asked to change the size of a bar using different strategies to vary the parameters of its current brain's states (neurofeedback training) computed on the realtime EEG signals.
Experimental: ADHD population group

The experimental design includes three sessions:

  • session 1 will be used to evaluate diagnostic using different targeted questionnaires.

  • sessions 2 and 3 will be decomposed into 3 consecutives parts:

    1. Pre evaluation
    2. Neurofeedback
    3. Post evaluation
Device: Neurofeedback
Neurofeedback training during which participant will be asked to change the size of a bar using different strategies to vary the parameters of its current brain's states (neurofeedback training) computed on the realtime EEG signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in microstate coverage during training
Time Frame: Change within session at week 1 (session 2) and week 2 (session 2)
Difference in EEG microstate time coverage (%) between training and rest periods for each session (session 2, session 3) independently.
Change within session at week 1 (session 2) and week 2 (session 2)
Change in microstate coverage during rest
Time Frame: Change within session week 1 (session 2) and week 2 (session 2)
Difference in EEG microstate time coverage (%) between rest periods for each session (session 2, session 3) independently.
Change within session week 1 (session 2) and week 2 (session 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between EEG microstate time coverage (%) and task performance: error rates (%) and reaction time.
Time Frame: Within session at week 1 (session 2) and week 2 (session 2)
Within session at week 1 (session 2) and week 2 (session 2)
Change in EEG Event Related potentiels before and after neurofeedback training.
Time Frame: Within session at week 1 (session 2) and week 2 (session 2)
For each condition (Go/NoGo) we will investigate differences in Global map dissimilarity (GMD), amplitude and microstate segmentation between pre and post neurofeedback training tasks.
Within session at week 1 (session 2) and week 2 (session 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nader Perroud

Collaborators

University Hospital, Geneva
University of Geneva, Switzerland

Investigators

  • Principal Investigator: Nader Perroud, Professor, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00848

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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