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

NCT ID: NCT04640766

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2022-10-18

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.

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).

Conditions

Attention Deficit Hyper Activity

Keywords

PRISM

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with ADHD

Group Type: EXPERIMENTAL

PRISM

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

EEG-based neurofeedback (EEG-NF) device

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lenard Adler, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-01086

Identifier Type: -

Identifier Source: org_study_id