N/A
N=9
Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
Attention Deficit Hyper Activity
Bottom Line
View on ClinicalTrials.gov: NCT04640766 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) — 35 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRISM (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) |
11.3 | — |
| PRIMARY Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) |
11.3 | — |
| PRIMARY Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) |
32.4 | — |
| PRIMARY Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) |
32.4 | — |
| PRIMARY Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report |
56.9 | — |
| PRIMARY Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report |
56.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04640766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.