Efficacy of Mobile Neurofeedback for Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT04112082 | Unknown

• 1 other identifier: 6362-19-SMC
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

neurofeedback; Attention Deficit Hyperactivity Disorder (ADHD); attention; executive function; electroencephalogram (EEG); adult ADHD; wearable sensors

Outcome Measures

Primary Outcomes (3)

• Change in Continuous Performance Task (CPT) Response Time

  mean response time for correct responses on a computerized CPT

  baseline, immediately after 10-week intervention period

• Change in Continuous Performance Task (CPT) Response Time Variability

  standard deviation of response time for correct responses on a computerized CPT

  baseline, immediately after 10-week intervention period

• Change in Self-Reported ADHD Symptoms

  total score on the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1)

  baseline, immediately after 10-week intervention period

Secondary Outcomes (13)

• EEG Theta Amplitude

  baseline, immediately after 10-week intervention period

• EEG Beta Amplitude

  baseline, immediately after 10-week intervention period

• EEG Theta/Beta Ratio

  baseline, immediately after 10-week intervention period

• Continuous Performance Task (CPT) Accuracy

  baseline, immediately after 10-week intervention period

• Continuous Performance Task (CPT) Commission Errors

  baseline, immediately after 10-week intervention period

Other Outcomes (1)

• Quality of Life Scores for Adult ADHD

  baseline, immediately after 10-week intervention period

Study Arms (2)

Home-Based Neurofeedback Training

EXPERIMENTAL

Behavioral: Mobile Neurofeedback

Treatment as Usual

ACTIVE COMPARATOR

Other: Treatment as Usual

Interventions

Mobile Neurofeedback BEHAVIORAL

Home-based neurofeedback training (downtrain theta, uptrain beta; training site: Cz) 4 times weekly for a 40 of total sessions over the ten-week training period. Session duration of 21 minutes for the first 20 sessions to 30 minutes for the last 20 sessions. Positive visual and auditory feedback when brainwaves are within the desired range.

Also known as: neurotherapy, electroencephalogram (EEG) biofeedback, brainwave biofeedback

Home-Based Neurofeedback Training

Treatment as Usual OTHER

Treatment plan as part of regular care at the ADHD clinic, which may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of pharmacological intervention and CBT, or no intervention. Care will often include pharmacological intervention, with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation considering such factors as response to previous interventions, participant characteristics, and practical constraints. Most pharmacological interventions will be stimulants (e.g., methylphenidate) with various release mechanisms. Each participant will receive an individualized dose titration and follow-up plan, including clinic visits as needed (generally 1-2 visits over the 10-week intervention period); interventions may be switched in accord with clinical judgment.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• neurofeedback treatment in the two years prior to baseline

Sponsors & Collaborators

• Sheba Medical Center: lead
• Myndlift Ltd.: collaborator

Related Publications (6)

• 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.

  PMID: 16923651 BACKGROUND

• 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.

  PMID: 16411036 BACKGROUND

• 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.

  PMID: 17162726 BACKGROUND

• 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.

  PMID: 25431555 BACKGROUND

• 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.

  PMID: 19715181 BACKGROUND

• 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.

  PMID: 30646779 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Biofeedback, Psychology; Neurofeedback; Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Tamir Epstein, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamir Epstein, MD

CONTACT

+972-50-640-8442; tamir.epstein@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit for Adult Developmental Disorders

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 2, 2019
• Study Start: December 22, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share