Efficacy of Mobile Neurofeedback for Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Behavioral: Mobile NeurofeedbackOther: Treatment as Usual
- Registration Number
- NCT04112082
- Lead Sponsor
- Sheba Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-Based Neurofeedback Training Mobile Neurofeedback - Treatment as Usual Treatment as Usual -
- Primary Outcome Measures
Name Time Method Change in Continuous Performance Task (CPT) Response Time Variability baseline, immediately after 10-week intervention period standard deviation of response time for correct responses on a computerized CPT
Change in Self-Reported ADHD Symptoms baseline, immediately after 10-week intervention period total score on the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1)
Change in Continuous Performance Task (CPT) Response Time baseline, immediately after 10-week intervention period mean response time for correct responses on a computerized CPT
- Secondary Outcome Measures
Name Time Method Continuous Performance Task (CPT) Omission Errors baseline, immediately after 10-week intervention period number of commission errors on a computerized CPT
Continuous Performance Task (CPT) Accuracy baseline, immediately after 10-week intervention period percent correct on a computerized CPT
Executive Function Domain Score from Cognitive Battery baseline, immediately after 10-week intervention period standardized executive function domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15
EEG Theta/Beta Ratio baseline, immediately after 10-week intervention period resting state fronto-central theta/beta ratio
Continuous Performance Task (CPT) Commission Errors baseline, immediately after 10-week intervention period number of commission errors on a computerized CPT
ADHD Screener Score baseline, immediately after 10-week intervention period 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
ADHD Symptom Inattention Subtype Score baseline, immediately after 10-week intervention period 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
Global Cognitive Score from Cognitive Battery baseline, immediately after 10-week intervention period global cognitive score (average of standardized domain scores) from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation: 15
Information Processing Speed Domain Score from Cognitive Battery baseline, immediately after 10-week intervention period standardized information processing speed domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15
EEG Theta Amplitude baseline, immediately after 10-week intervention period resting state fronto-central theta amplitude
EEG Beta Amplitude baseline, immediately after 10-week intervention period resting state fronto-central beta amplitude
Attention Domain Score from Cognitive Battery baseline, immediately after 10-week intervention period standardized attention domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15
ADHD Symptom Hyperactivity/Impulsivity Subtype Score baseline, immediately after 10-week intervention period 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