An interventional study of PRISM in Attention Deficit Hyper Activity, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
This is a single-arm, open-label feasibility study. Participants will be assigned and will undergo a novel neurofeedback intervention, targeting down-regulation of deep limbic structures, specifically the amygdalae. Participants will complete 12 neurofeedback sessions delivered twice weekly over 6 consecutive weeks. The intervention will be delivered via the PRISM platform.
The objectives include: 1)Training the NYU team on the electric finger print electroencephalography neurofeedback (EFP-EEG-NF) technology and provide them with hands-on experience; 2) Assessing participants' ability to learn the feedback paradigm (i.e. control the EFP-EEG-NF signal; time to achieve learning; assess learning curves); 3) Exploring preliminary results assessing target symptoms (e.g. AISRS and BRIEF-A).
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 18 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: PRISM
The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.
Also known as: EEG-based neurofeedback (EEG-NF) device
Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
ADHD symptoms will also be measured using the Adult ADHD Investigator Symptom Rating Scale (AISRS). Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. The higher the score, the more severe the symptoms.
Time frame: Baseline
Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
ADHD symptoms will also be measured using the Adult ADHD Investigator Symptom Rating Scale (AISRS). Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. The higher the score, the more severe the symptoms.
Time frame: Week 9
Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)
The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.
Time frame: Baseline
Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)
The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.
Time frame: Week 11
Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report
Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.
Time frame: Baseline
Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report
Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.
Time frame: Week 11
| Milestone | Participants With ADHD |
|---|---|
| Started | 9 |
| Completed | 7 |
| Not completed | 2 |
| Withdrew: Withdrawn for inconsistency with visits and change in current medication | 2 |
ADHD symptoms will also be measured using the Adult ADHD Investigator Symptom Rating Scale (AISRS). Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. The higher the score, the more severe the symptoms.
| score on a scale | Participants With ADHD |
|---|---|
| Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | 35 ± 5.5 |
ADHD symptoms will also be measured using the Adult ADHD Investigator Symptom Rating Scale (AISRS). Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. The higher the score, the more severe the symptoms.
| score on a scale | Participants With ADHD |
|---|---|
| Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | 11.3 ± 6.9 |
The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.
| score on a scale | Participants With ADHD |
|---|---|
| Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) | 47.1 ± 3.3 |
The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.
| score on a scale | Participants With ADHD |
|---|---|
| Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) | 32.4 ± 6.4 |
Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.
| score on a scale | Participants With ADHD |
|---|---|
| Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report | 75.6 ± 7.6 |
Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.
| score on a scale | Participants With ADHD |
|---|---|
| Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report | 56.9 ± 9.6 |
Collected over 11 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With ADHD | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Event | Participants With ADHD |
|---|---|
| HeadacheNervous system disorders | 2/9 |
| Insomnia + Vivid DreamsPsychiatric disorders | 1/9 |
| Soreness in JawMusculoskeletal and connective tissue disorders | 1/9 |
| Gastrointestinal discomfortGastrointestinal disorders | 1/9 |
The baseline analysis population comprises individuals who began treatment in the study (n = 9).
| Age, Continuous(years) | Participants With ADHD |
|---|---|
| Mean | 33 ± 8.8 |
| Sex: Female, Male(Participants) | Participants With ADHD |
|---|---|
| Female | 7 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Participants With ADHD |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Participants With ADHD |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Participants With ADHD |
|---|---|
| United States | 9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting information: Study protocol, Sap
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
NYU Langone Health