search
Back to results

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

Primary Purpose

Attention Deficit Hyper Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRISM
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyper Activity focused on measuring PRISM

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with ADHD

Arm Description

Outcomes

Primary Outcome Measures

Time to achieve learning of feedback paradigm
The time it takes for participants' to learn the feedback paradigm (control of the EEG-NF signal) will be reported
Change in 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.
Change in Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5 (DSM-5 ASRS)
DSM-5 (ASRS) consists of 6 questions. Each question is scored in the range 0-4, for a total range of score of 0-24. The higher the score, the more difficulty the participant is experiencing handling ADHD.
Change in 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.
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) will be utilized to objectify degree of depression severity. PHQ-9 is composed of 10 questions. The total range of score is 0-27 (the higher the score, the more severe the depression): 0-4 indicates minimal depression 6-9 indicates mild depression 10-14 indicates moderate depression 15-19 indicates moderately severe depression 20-27 indicates severe depression
Change in Score on Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) will be used to measure participants' quality and patterns of sleep. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
December 16, 2022
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT04640766
Brief Title
Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
Official Title
Feasibility Open Label Study Evaluating the Use of Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-arm, open-label feasibility study. A maximum of 30 participants will be enrolled. 15 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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyper Activity
Keywords
PRISM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with ADHD
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PRISM
Other Intervention Name(s)
EEG-based neurofeedback (EEG-NF) device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to achieve learning of feedback paradigm
Description
The time it takes for participants' to learn the feedback paradigm (control of the EEG-NF signal) will be reported
Time Frame
Up to week 6
Title
Change in Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
Description
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
Between week 0 and week 9
Title
Change in Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5 (DSM-5 ASRS)
Description
DSM-5 (ASRS) consists of 6 questions. Each question is scored in the range 0-4, for a total range of score of 0-24. The higher the score, the more difficulty the participant is experiencing handling ADHD.
Time Frame
Between week 0 and week 9
Title
Change in Score on Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report
Description
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
Between week 0 and week 9
Title
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
Description
The Patient Health Questionnaire-9 (PHQ-9) will be utilized to objectify degree of depression severity. PHQ-9 is composed of 10 questions. The total range of score is 0-27 (the higher the score, the more severe the depression): 0-4 indicates minimal depression 6-9 indicates mild depression 10-14 indicates moderate depression 15-19 indicates moderately severe depression 20-27 indicates severe depression
Time Frame
Between week 0 and week 9
Title
Change in Score on Pittsburgh Sleep Quality Index (PSQI)
Description
Pittsburgh Sleep Quality Index (PSQI) will be used to measure participants' quality and patterns of sleep. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Time Frame
Between week 0 and week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenard Adler, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs