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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
NEUROFEEDBACK
CONTROL
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Electroencephalography, Alpha Rhythm, Attention, Impulsive Behavior, Neurofeedback

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of GenevaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NEUROFEEDBACK

CONTROL

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in assessor-evaluated clinical ADHD status
Change in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)
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 in Alpha Spectral Power
Absolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)
Change in reaction time at the Continuous Performance Task (CPT)
Reaction time and reaction time variability (milliseconds)
Change in error rates at the CPT
Number of omission and commission errors

Secondary Outcome Measures

Full Information

First Posted
May 12, 2020
Last Updated
May 17, 2022
Sponsor
University Hospital, Geneva
Collaborators
University of Geneva, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04408521
Brief Title
Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents
Acronym
NFB@HOME
Official Title
Effect of Long-lasting EEG-Neurofeedback on Attention Control and Impulsivity in Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
University of Geneva, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Electroencephalography, Alpha Rhythm, Attention, Impulsive Behavior, Neurofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEUROFEEDBACK
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
NEUROFEEDBACK
Intervention Description
EEG recording during alpha-related TV viewing
Intervention Type
Other
Intervention Name(s)
CONTROL
Intervention Description
EEG recording during passive TV viewing
Primary Outcome Measure Information:
Title
Change in assessor-evaluated clinical ADHD status
Description
Change in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)
Time Frame
Change between day 10 pre-intervention and day 10 post-intervention
Title
Change in self-reported clinical ADHD status
Description
Change in adult ADHD Self-Report Scale (ASRS) scoring (min = 0, max = 72, higher score = worse outcome)
Time Frame
Change between day 10 pre-intervention and day 10 post-intervention
Title
Change in Alpha Spectral Power
Description
Absolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)
Time Frame
Change between day 2 pre-intervention and day 2 post-intervention
Title
Change in reaction time at the Continuous Performance Task (CPT)
Description
Reaction time and reaction time variability (milliseconds)
Time Frame
Change between day 2 pre-intervention and day 2 post-intervention
Title
Change in error rates at the CPT
Description
Number of omission and commission errors
Time Frame
Change between day 2 pre-intervention and day 2 post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nader Perroud, MD
Phone
+41 22 305 45 11
Email
nader.perroud@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Pierre Deiber, PhD
Phone
+41 22 305 53 80
Email
marie-pierre.deiber@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Dayer, MD, PhD
Organizational Affiliation
University of Geneva & University Hospitals of Geneva
Official's Role
Study Director
Facility Information:
Facility Name
University Hospitals of Geneva
City
Geneva
ZIP/Postal Code
1201
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nader Perroud, MD
Phone
+41 22 305 45 11
Email
nader.perroud@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Marie Pierre Deiber, PhD
Phone
+41 22 305 53 80
Email
marie-pierre.deiber@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Tomas Ros, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19715181
Citation
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.
Results Reference
background
PubMed Identifier
15268915
Citation
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.
Results Reference
background
PubMed Identifier
21687452
Citation
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.
Results Reference
background
PubMed Identifier
25431555
Citation
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.
Results Reference
background
PubMed Identifier
25957598
Citation
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.
Results Reference
background
PubMed Identifier
31911342
Citation
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.
Results Reference
result

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Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

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