Clinical trial NCT04112082: Efficacy of Mobile Neurofeedback for Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: Efficacy of Mobile Neurofeedback for Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: neurofeedback
Attention Deficit Hyperactivity Disorder (ADHD)
attention
executive function
electroencephalogram (EEG)
adult ADHD
wearable sensors
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Myndlift Ltd.
First posted: 2019-10-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an assessor-blind, parallel-group, controlled trial to evaluate the benefit of home-based training with a low-cost, mobile neurofeedback system (Myndlift) in adults with ADHD. Randomized controlled trials have shown significant benefit for neurofeedback, including persistent effects without the side effects of psychostimulants (i.e., diminished appetite, insomnia, anxiety, irritability). However, standard application requires clinic visits and significant expense, limiting training frequency and compromising potential efficacy. Additionally, extant evidence for efficacy comes almost exclusively from children and adolescents, with very few studies in adults. The present trial will measure the ability of home-based neurofeedback using a low-cost, user-friendly system to ameliorate symptomatology (e.g., enhancing attention, reducing impulsive behavior) in adults with ADHD. Participants will receive either neurofeedback or treatment as usual (TAU). Primary outcomes will be objective scores on a continuous performance task (CPT) and subjective report on a standardized adult ADHD symptoms questionnaire. Eligible participants recruited from an adult ADHD clinic will complete a baseline assessment (1.25 hours) including subjective questionnaires, computerized cognitive assessment, and resting-state EEG administered by a blinded assessor. The experimental group will train at home with a neurofeedback headset and tablet 4 times/week for ten weeks (session duration: 21-30 minutes). Neurofeedback will be provided via a conventional theta beta protocol in which participants train using gamified tasks, videos, or audio clips in a tablet-based app, and receive positive visual/auditory feedback when their brainwaves are in the desired range. The control group will follow the regular treatment plan set by the clinic (i.e., treatment as usual; TAU). Care may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of both, or no intervention. Care will often include pharmacological intervention (e.g., methylphenidate), with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation. After completing the ten-week intervention period, all participants will return to the clinic for a follow-up assessment identical to the baseline assessment. It is hypothesized that home-based neurofeedback training will demonstrate non-inferiority to TAU as measured by improvement in subjective and objective symptoms.


Eligibility criteria: Inclusion Criteria:

* willingness to provide consent
* diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) of any type as ascertained by clinical interview conducted by a board-certified psychiatrist
* at the time of enrollment, not receiving treatment for symptoms of ADHD

Exclusion Criteria:

* comorbid psychotic or bipolar disorder or an active affective disorder
* medical disorder with potentially confounding psychiatric effects (either due to direct effects of the condition or medication effects)
* diagnosis of substance abuse disorder (SUD), sleep apnea, restless legs syndrome (RLS), or borderline intellectual functioning
* unable to attend in-clinic follow-up assessment
* antipsychotic agent in the three months prior to baseline assessment
* any selective serotonin reuptake inhibitor (SSRI) treatment in the four weeks prior to baseline
* other psychiatric medication in the two weeks prior to baseline that the principal investigator deems to be confounding
* experimental group only: plans to start stimulant medication during the course of the study (use of nutritional supplements including "prescription medical foods" is not exclusionary)
* neurofeedback treatment in the two years prior to baseline

Primary outcomes:
measure: Change in Continuous Performance Task (CPT) Response Time
timeFrame: baseline, immediately after 10-week intervention period
measure: Change in Continuous Performance Task (CPT) Response Time Variability
timeFrame: baseline, immediately after 10-week intervention period
measure: Change in Self-Reported ADHD Symptoms
timeFrame: baseline, immediately after 10-week intervention period
Secondary outcomes:
measure: EEG Theta Amplitude
timeFrame: baseline, immediately after 10-week intervention period
measure: EEG Beta Amplitude
timeFrame: baseline, immediately after 10-week intervention period
measure: EEG Theta/Beta Ratio
timeFrame: baseline, immediately after 10-week intervention period
measure: Continuous Performance Task (CPT) Accuracy
timeFrame: baseline, immediately after 10-week intervention period
measure: Continuous Performance Task (CPT) Commission Errors
timeFrame: baseline, immediately after 10-week intervention period
measure: Continuous Performance Task (CPT) Omission Errors
timeFrame: baseline, immediately after 10-week intervention period
measure: ADHD Screener Score
timeFrame: baseline, immediately after 10-week intervention period
measure: ADHD Symptom Inattention Subtype Score
timeFrame: baseline, immediately after 10-week intervention period
measure: ADHD Symptom Hyperactivity/Impulsivity Subtype Score
timeFrame: baseline, immediately after 10-week intervention period
measure: Global Cognitive Score from Cognitive Battery
timeFrame: baseline, immediately after 10-week intervention period
measure: Attention Domain Score from Cognitive Battery
timeFrame: baseline, immediately after 10-week intervention period
measure: Executive Function Domain Score from Cognitive Battery
timeFrame: baseline, immediately after 10-week intervention period
measure: Information Processing Speed Domain Score from Cognitive Battery
timeFrame: baseline, immediately after 10-week intervention period
Other outcomes:
measure: Quality of Life Scores for Adult ADHD
timeFrame: baseline, immediately after 10-week intervention period
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Tamir Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
citation: Brod M, Johnston J, Able S, Swindle R. Validation of the adult attention-deficit/hyperactivity disorder quality-of-life Scale (AAQoL): a disease-specific quality-of-life measure. Qual Life Res. 2006 Feb;15(1):117-29. doi: 10.1007/s11136-005-8325-z.
citation: Schweiger A, Abramovitch A, Doniger GM, Simon ES. A clinical construct validity study of a novel computerized battery for the diagnosis of ADHD in young adults. J Clin Exp Neuropsychol. 2007 Jan;29(1):100-11. doi: 10.1080/13803390500519738.
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.
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.
citation: Riesco-Matias P, Yela-Bernabe JR, Crego A, Sanchez-Zaballos E. What Do Meta-Analyses Have to Say About the Efficacy of Neurofeedback Applied to Children With ADHD? Review of Previous Meta-Analyses and a New Meta-Analysis. J Atten Disord. 2021 Feb;25(4):473-485. doi: 10.1177/1087054718821731. Epub 2019 Jan 15.