Clinical trial NCT04640766: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyper Activity
Keywords: PRISM
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
timeFrame: Baseline
measure: Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
timeFrame: Week 9
measure: Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)
timeFrame: Baseline
measure: Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)
timeFrame: Week 11
measure: Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report
timeFrame: Baseline
measure: Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report
timeFrame: Week 11
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lenard Adler, MD
role: PRINCIPAL_INVESTIGATOR
References: