Attention Deficit Hyper Activity
Conditions
Keywords
PRISM
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).
Interventions
DEVICEPRISM
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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline | 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. |
| Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) | Baseline | 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. |
| Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report | Baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
18 participants were enrolled; 9 of these participants failed screening. 9 participants started treatment.
Participants by arm
| Arm | Count |
|---|---|
| Participants With ADHD 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. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawn for inconsistency with visits and change in current medication | 2 |
Baseline characteristics
| Characteristic | Participants With ADHD |
|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 3 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With ADHD | Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | 35 score on a scale | Standard Deviation 5.5 |
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.
Time frame: Week 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With ADHD | Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | 11.3 score on a scale | Standard Deviation 6.9 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With ADHD | Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) | 47.1 score on a scale | Standard Deviation 3.3 |
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.
Time frame: Week 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With ADHD | Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded) | 32.4 score on a scale | Standard Deviation 6.4 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With ADHD | Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report | 75.6 score on a scale | Standard Deviation 7.6 |
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.
Time frame: Week 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With ADHD | Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report | 56.9 score on a scale | Standard Deviation 9.6 |