Attention Deficit Hyper Activity Clinical Trial
Official title:
Feasibility Open Label Study Evaluating the Use of Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
NCT number | NCT04640766 |
Other study ID # | 20-01086 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 26, 2021 |
Est. completion date | October 18, 2022 |
Verified date | November 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | October 18, 2022 |
Est. primary completion date | October 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | 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 | |
Primary | Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | 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 | |
Primary | Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) | 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 | |
Primary | Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) | 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 | |
Primary | Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report | 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 | |
Primary | Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
Recruiting |
NCT05924594 -
Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
|
Phase 3 | |
Active, not recruiting |
NCT05286762 -
Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301
|
Phase 3 | |
Completed |
NCT04158960 -
Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks
|
N/A |