Focused Ultrasound for the Treatment of ADHD Symptoms

Study Overview
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Brief Summary
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The purpose of this open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with attention deficit hyperactive disorder (ADHD).

Detailed Description
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The primary cortical regions thought to be implicated in ADHD include the prefrontal, orbitofrontal, and anterior cingulate cortices. A possible treatment approach for ADHD would employ a process designed to promote healthier function of the anterior cingulate region. The anterior cingulate in particular appears to be implicated in the activation of cognitive control networks, and has been posited as an area of interest for therapeutic research on ADHD. The subjects in this research study will be recruited through medical practice and enrolled in an 8-week protocol to undergo 8 consecutive weekly ultrasound sessions.

Official Title
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Open Label Study for the Use of Transcranial Ultrasound Treatment of Attention Deficit Hyperactive Disorder

Conditions
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ADHD

Intervention / Treatment
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* Device: Brainsonix Pulsar 1002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Attention Deficit Hyperactive Disorder (ADHD) Failure to respond to traditional symptom management (e.g. stimulants, psychoeducation, cognitive-behavior therapy, etc.) Score of at least 8 (4 ADHD-positive items) on the Adult ADHD Self-Report Questionnaire (ASRS-V1.1) At least 18 years of age Exclusion Criteria: • Subjects unable to give informed consent Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep Recent surgery or dental work within 3 months of the scheduled procedure. Pregnancy, women who may become pregnant or are breastfeeding Advanced terminal illness Any active cancer or chemotherapy Any other neoplastic illness or illness characterized by neovascularity Macular degeneration Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer) Advanced kidney, pulmonary, cardiac or liver failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focused Ultrasound<br>On the day of the ultrasound appointment, patients will undergo ten minutes of ultrasound targeting the anterior cingulate. The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the anterior cerebral artery, and optical tracking technology (e.g., AntNeuro Visor2™ system) may be used in tandem with the Brainsonix ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement. | Device: Brainsonix Pulsar 1002<br>* Each participant will undergo 8 consecutive weekly sessions (each session is 10 minutes long) of focused ultrasound with the Brainsonix Pulsar 1002 device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD Self-Report Scale (ASRS-v1.1) | This instrument is designed to evaluate for severity of symptoms as specified in the DSM-IV-TR. The ASRS is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the never, rarely, sometimes, often, very often column for a possible total score of 72. The minimum score to qualify for study inclusion is 8 (i.e., 4 or more symptom-positive answers), and the maximum possible score is 72. The higher the score, the more indicative of higher severity of ADHD symptoms. Each column is used to describe the severity of the individuals symptoms based on the questions asked. Each participant is asked to make a mark within one column for each question that best describes their answer. The first 6 questions of the scale comprise Part A, which is more generally used as a screening measure. Questions 12-18 comprise Part B, which provides further identifying clues for individual symptoms. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD Self-Report Scale (ASRS-v1.1) | This instrument is designed to evaluate for severity of symptoms as specified in the DSM-IV-TR. The ASRS is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the never, rarely, sometimes, often, very often column for a possible total score of 72. The higher the score, the more indicative of higher severity of ADHD symptoms. Each column is used to describe the severity of the individuals symptoms based on the questions asked. Each participant is asked to make a mark within one column for each question that best describes their answer. The first 6 questions of the scale comprise Part A, which is more generally used as a screening measure. Questions 12-18 comprise Part B, which provides further identifying clues for individual symptoms. Improvement will be gauged by reduction in overall score (minimally clinically important difference will be 20% for this study). | Post Final Treatment (8 weeks from baseline) |