Focused Ultrasound for the Treatment of ADHD Symptoms

Neurological Associates of West Los Angeles

Status: Invitation-only

Conditions: ADHD

Treatments: Device: Brainsonix Pulsar 1002

Study type: Interventional

Funder types: Other

Identifiers

NCT04497363

fUS_ADHD

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Focused Ultrasound

Experimental group

Description:

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.

Treatment:

Device: Brainsonix Pulsar 1002