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Attention Deficit Disorder With HyperactivityNFB@HOMENCT04408521

Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

A study testing NEUROFEEDBACK in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Geneva at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
NEUROFEEDBACK
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
1 siteSwitzerland
Study dates
2 Nov 2020to Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Mood Disorders
  • PTSD
  • Borderline Personality Disorder
  • Substance Use Disorder
  • Structural Brain Abnormalities
  • Cerebrovascular Disease
Show all 13Show fewer
  • Epilepsy
  • Stroke
  • Head Trauma
  • Cardiovascular Disease
  • Renal Failure
  • Hepatic Dysfunction
  • Impaired visual acuity

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospitals of Geneva

    Geneva, 1201

Other trials in Switzerland

About this study

Official title: 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.

Being tested
NEUROFEEDBACK, CONTROL
Keywords
Electroencephalography, Alpha Rhythm, Attention, Impulsive Behavior, Neurofeedback
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Impulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEUROFEEDBACKOther

    EEG recording during alpha-related TV viewing

  • CONTROLOther

    EEG recording during passive TV viewing

Study groups in NCT04408521
Study groupRoleWhat they receive
NEUROFEEDBACKExperimentalParticipants 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.
Receives: Other: NEUROFEEDBACK
CONTROLPlacebo comparatorParticipants 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).
Receives: Other: CONTROL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in assessor-evaluated clinical ADHD status

    Change in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)

    Measured: Change between day 10 pre-intervention and day 10 post-intervention

  2. Change in self-reported clinical ADHD status

    Change in adult ADHD Self-Report Scale (ASRS) scoring (min = 0, max = 72, higher score = worse outcome)

    Measured: Change between day 10 pre-intervention and day 10 post-intervention

  3. Change in Alpha Spectral Power

    Absolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)

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

  4. Change in reaction time at the Continuous Performance Task (CPT)

    Reaction time and reaction time variability (milliseconds)

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

  5. Change in error rates at the CPT

    Number of omission and commission errors

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start2 Nov 2020
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04408521
Sponsor's protocol ID
2017-01029
Other IDs
SNCTP000002260, 2017
Acronym
NFB@HOME
Status last verified
Nov 2023
First submitted
12 May 2020
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19715181

  • 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.

    PubMed 15268915

  • 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.

    PubMed 21687452

  • 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.

    PubMed 25431555

  • 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.

    PubMed 25957598

  • 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.

    PubMed 31911342

Questions about this trial

What is this clinical trial studying?

A study testing NEUROFEEDBACK in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in assessor-evaluated clinical ADHD status (time frame: Change between day 10 pre-intervention and day 10 post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04408521, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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NFB@HOME Clinical Trial NCT04408521 | AzTrials