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

NCT04640766 | Completed Results FDA Device

• 1 other identifier: 20-01086
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyper Activity

Keywords

PRISM

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Week 11

Study Arms (1)

Participants with ADHD

EXPERIMENTAL

Device: PRISM

Interventions

PRISM DEVICE

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

Participants with ADHD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ages 18-60 years, inclusive at the time of consent
• Able to provide signed informed consent
• Any gender
• Subjects with a current primary DSM-5 diagnosis of ADHD (including predominantly inattentive presentation, hyperactive presentation, or combined presentations) as confirmed by the ACDS Version 1.2.
• Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS score of ≥ 28 at screening. Subjects who are receiving pharmacological treatment for ADHD at screening must have a minimum AISRS score of ≥ 22 at screening
• Not requiring treatment for any comorbid psychiatric condition for at least 2 months
• Normal or corrected-to-normal vision
• Normal or corrected-to-normal hearing
• No intention of changing medication or psychotherapy for the duration of the study at the time of recruitment

You may not qualify if:

• Concurrent substance abuse and/or history of substance use within 6 months
• Use of any prescribed benzodiazepine
• Lifetime bipolar disorder, psychotic disorder, autism, intellectual disability. Comorbid mood and anxiety disorders determined by the MINI will be permitted if they are not the primary focus of clinical attention
• Active suicidality within past year, or history of suicide attempt in past 2 years
• Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
• Any unstable medical or neurological condition
• Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury \[TBI\] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
• Any psychotropic medication
• Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy \[CPT\], Prolonged Exposure \[PE\], Eye Movement Desensitization and Reprocessing \[EMDR\]); continuation of established maintenance supportive therapy will be permitted
• Significant hearing loss or severe sensory impairment
• Enrollment in another research study testing an experimental, clinical, or behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Results Point of Contact

• Title: Lenard Adler, MD
• Organization: NYU Langone Health

Lenard.Adler@nyulangone.org

212-263-3580

Study Officials

• Lenard Adler, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 23, 2020
• Study Start: July 26, 2021
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Lenard.Adler@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)