Clinical trial NCT04497363: Focused Ultrasound for the Treatment of ADHD Symptoms
Official title: Open Label Study for the Use of Transcranial Ultrasound Treatment of Attention Deficit Hyperactive Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: ADHD
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adult ADHD Self-Report Scale (ASRS-v1.1)
timeFrame: Baseline
Secondary outcomes:
measure: Adult ADHD Self-Report Scale (ASRS-v1.1)
timeFrame: Post Final Treatment (8 weeks from baseline)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West LA
state: California
city: Santa Monica
country: United States
facility: Neurological Associates of West Los Angele
state: California
Study officials:
affiliation: Neurological Associates of West Los Angeles
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
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