NCT04640766

Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults

Completed NA Results posted Last updated 12 December 2023

What this trial tests

NA trial testing PRISM in Attention Deficit Hyper Activity in 18 participants. Completed in 18 October 2022.

Timeline

26 July 2021

Primary endpoint
18 October 2022

18 October 2022

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	26 July 2021
Primary completion	18 October 2022
Estimated completion	18 October 2022
Sites	1 location across United States

Drugs / interventions tested

• PRISM

Conditions studied

• Attention Deficit Hyper Activity — all drugs for Attention Deficit Hyper Activity →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 60, any sex, with Attention Deficit Hyper Activity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) Primary · Baseline

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.

Group	Value	95% CI
Participants With ADHD	35	± 5.5

Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) Primary · Week 9

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.

Group	Value	95% CI
Participants With ADHD	11.3	± 6.9

Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) Primary · Baseline

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.

Group	Value	95% CI
Participants With ADHD	47.1	± 3.3

Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) Primary · Week 11

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.

Group	Value	95% CI
Participants With ADHD	32.4	± 6.4

Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report Primary · Baseline

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.

Group	Value	95% CI
Participants With ADHD	75.6	± 7.6

Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report Primary · Week 11

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.

Group	Value	95% CI
Participants With ADHD	56.9	± 9.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 11 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With ADHD

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (4 terms — click to expand)

Reaction	System	Participants With ADHD
Headache	Nervous system disorders	—
Insomnia + Vivid Dreams	Psychiatric disorders	—
Soreness in Jaw	Musculoskeletal and connective tissue disorders	—
Gastrointestinal discomfort	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT04640766 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.