Trial Outcomes & Findings for Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults (NCT NCT04640766)

Last Updated: 2023-12-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Baseline

Results posted on

2023-12-12

Participant Flow

18 participants were enrolled; 9 of these participants failed screening. 9 participants started treatment.

Participant milestones

Participant milestones
Measure	Participants With ADHD 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.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With ADHD 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.
Overall Study Withdrawn for inconsistency with visits and change in current medication	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With ADHD n=9 Participants 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.
Age, Continuous	33 years STANDARD_DEVIATION 8.8 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	9 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Participants With ADHD n=9 Participants 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.
Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)	35 score on a scale Standard Deviation 5.5

PRIMARY outcome

Timeframe: Week 9

Outcome measures

Outcome measures
Measure	Participants With ADHD n=9 Participants 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.
Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)	11.3 score on a scale Standard Deviation 6.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants With ADHD n=9 Participants 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.
Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)	47.1 score on a scale Standard Deviation 3.3

PRIMARY outcome

Timeframe: Week 11

Outcome measures

Outcome measures
Measure	Participants With ADHD n=9 Participants 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.
Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)	32.4 score on a scale Standard Deviation 6.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants With ADHD n=9 Participants 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.
Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report	75.6 score on a scale Standard Deviation 7.6

PRIMARY outcome

Timeframe: Week 11

Outcome measures

Outcome measures
Measure	Participants With ADHD n=9 Participants 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.
Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report	56.9 score on a scale Standard Deviation 9.6

Adverse Events

Participants With ADHD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With ADHD n=9 participants at risk 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.
Psychiatric disorders Insomnia + Vivid Dreams	11.1% 1/9 • 11 Weeks PI monitored for adverse events at every follow-up visit.
Musculoskeletal and connective tissue disorders Soreness in Jaw	11.1% 1/9 • 11 Weeks PI monitored for adverse events at every follow-up visit.
Nervous system disorders Headache	22.2% 2/9 • 11 Weeks PI monitored for adverse events at every follow-up visit.
Gastrointestinal disorders Gastrointestinal discomfort	11.1% 1/9 • 11 Weeks PI monitored for adverse events at every follow-up visit.

Additional Information

Lenard Adler, MD

NYU Langone Health

Phone: 212-263-3580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place