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

Study Overview
=================
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.

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

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Behavioral: Mobile Neurofeedback
* Other: Treatment as Usual


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-Based Neurofeedback Training<br> | Behavioral: Mobile Neurofeedback<br>* 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.<br>* Other names: brainwave biofeedback;|
| Active Comparator: Treatment as Usual<br> | Other: Treatment as Usual<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG Theta Amplitude | resting state fronto-central theta amplitude | baseline, immediately after 10-week intervention period | 
| EEG Beta Amplitude | resting state fronto-central beta amplitude | baseline, immediately after 10-week intervention period | 
| EEG Theta/Beta Ratio | resting state fronto-central theta/beta ratio | baseline, immediately after 10-week intervention period | 
| Continuous Performance Task (CPT) Accuracy | percent correct on a computerized CPT | baseline, immediately after 10-week intervention period | 
| Continuous Performance Task (CPT) Commission Errors | number of commission errors on a computerized CPT | baseline, immediately after 10-week intervention period | 
| Continuous Performance Task (CPT) Omission Errors | number of commission errors on a computerized CPT | baseline, immediately after 10-week intervention period | 
| ADHD Screener Score | sum of item scores for the first 6 items (Part A) of the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1); item ratings: 0=never, 1=rarely, 2=sometimes, 3=often, 4=very often; scoring: for items 1-3, ratings of sometimes, often, or very often are assigned one point; for items 4-6 ratings of often or very often are assigned one point; a higher score reflects a worse outcome | baseline, immediately after 10-week intervention period | 
| ADHD Symptom Inattention Subtype Score | sum of item scores for the 9 inattention items from the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1): items 1-4 & 7-11; item ratings: 0=never, 1=rarely, 2=sometimes, 3=often, 4=very often; scoring: for items 1-3 & 9, ratings of sometimes, often, or very often are assigned one point; for items 4, 7, 8, 10 & 11, ratings of often or very often are assigned one point; a higher score reflects a worse outcome | baseline, immediately after 10-week intervention period | 
| ADHD Symptom Hyperactivity/Impulsivity Subtype Score | sum of item scores for the 9 hyperactivity/impulsivity items from the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1): items 5-6 & 12-18; item ratings: 0=never, 1=rarely, 2=sometimes, 3=often, 4=very often; scoring: for items 12 & 18, ratings of sometimes, often, or very often are assigned one point; for items 5-6 & 13-17, ratings of often or very often are assigned one point; a higher score reflects a worse outcome | baseline, immediately after 10-week intervention period | 
| Global Cognitive Score from Cognitive Battery | global cognitive score (average of standardized domain scores) from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation: 15 | baseline, immediately after 10-week intervention period | 
| Attention Domain Score from Cognitive Battery | standardized attention domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15 | baseline, immediately after 10-week intervention period | 
| Executive Function Domain Score from Cognitive Battery | standardized executive function domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15 | baseline, immediately after 10-week intervention period | 
| Information Processing Speed Domain Score from Cognitive Battery | standardized information processing speed domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15 | baseline, immediately after 10-week intervention period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurofeedback, Attention Deficit Hyperactivity Disorder (ADHD), attention, executive function, electroencephalogram (EEG), adult ADHD, wearable sensors