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| Name | Class |
|---|---|
| Myndlift Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-Based Neurofeedback Training | Experimental |
| |
| Treatment as Usual | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Scores for Adult ADHD | Adult ADHD Quality-of-Life Scale (AAQoL) overall score (29 items); life productivity (11 items), psychological health (6 items), life outlook (7 items), relationships (5 items) subscores from Adult ADHD Quality-of-Life Scale (AAQoL); items rated on five-point Likert scale from 'not at all/never' (1) to 'extremely/very often' (5); overall and subscale scores computed by reversing item scores for negatively worded items and transforming item scores to a 0-100 point scale; item scores summed and divided by item count; a higher score reflects a better outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamir Epstein, MD | Contact | +972-50-640-8442 | tamir.epstein@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Tamir Epstein, MD | Sheba Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16923651 | Background | 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. | |
| 16411036 | 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. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D058765 | Neurofeedback |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| 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. |
|
| 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 |
| baseline, immediately after 10-week intervention period |
| 17162726 | 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. |
| 25431555 | 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. |
| 19715181 | 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. |
| 30646779 | 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. |
| D004191 |
| Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |