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N/A N=9 Treatment

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

Attention Deficit Hyper Activity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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