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

November 28, 2023 updated by: Nader Perroud, University Hospital, Geneva

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

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 Locations

  • Switzerland
      • Geneva, Switzerland, 1201
        • University Hospitals of Geneva

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: NEUROFEEDBACK
EEG recording during alpha-related TV viewing
Placebo Comparator: 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).
Other: CONTROL
EEG recording during passive TV viewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in assessor-evaluated clinical ADHD status
Time Frame: 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 between day 10 pre-intervention and day 10 post-intervention
Change in self-reported clinical ADHD status
Time Frame: 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 between day 10 pre-intervention and day 10 post-intervention
Change in Alpha Spectral Power
Time Frame: 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 between day 2 pre-intervention and day 2 post-intervention
Change in reaction time at the Continuous Performance Task (CPT)
Time Frame: Change between day 2 pre-intervention and day 2 post-intervention
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
Time Frame: Change between day 2 pre-intervention and day 2 post-intervention
Number of omission and commission errors
Change between day 2 pre-intervention and day 2 post-intervention

Collaborators and Investigators

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

Sponsor

University Hospital, Geneva

Collaborators

University of Geneva, Switzerland

Investigators

  • Study Director: Alexandre Dayer, MD, PhD, University of Geneva & University Hospitals of 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)

November 2, 2020

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 29, 2020

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01029
  • SNCTP000002260 (Registry Identifier: Kofam.ch (Koordinationsstelle Forschung am Menschen))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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