- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04640766
Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
November 17, 2023 updated by: NYU Langone Health
Feasibility Open Label Study Evaluating the Use of Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
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.
Study Overview
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).
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10016
- NYU Langone Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants with ADHD
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
Time Frame: 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.
|
Baseline
|
Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
Time Frame: 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.
|
Week 9
|
Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)
Time Frame: 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.
|
Baseline
|
Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)
Time Frame: 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.
|
Week 11
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Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report
Time Frame: 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.
|
Baseline
|
Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report
Time Frame: 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.
|
Week 11
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lenard Adler, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2021
Primary Completion (Actual)
October 18, 2022
Study Completion (Actual)
October 18, 2022
Study Registration Dates
First Submitted
November 18, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 23, 2020
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-01086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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