Focused Ultrasound for ADHD

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Cancer, Advanced organ failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if using sound waves to stimulate the brain can help people with ADHD by improving areas that control attention and behavior. Recent research has shown that acoustic white noise can improve task performance in people with attention deficits and/or ADHD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How does the treatment Brainsonix Pulsar 1002 differ from other ADHD treatments?

The Brainsonix Pulsar 1002 treatment uses focused ultrasound, a non-invasive method that can modulate brain activity by altering blood flow and neural connectivity, which is different from traditional ADHD treatments that often involve medication. This approach is unique because it targets the brain's neurovascular coupling and connectivity, potentially improving brain function without the need for drugs. ^{1 2 3 4 5}

Research Team

Sheldon Jordan, MD

Principal Investigator

Neurological Associates of West Los Angeles

Eligibility Criteria

Adults diagnosed with ADHD who haven't had success with standard treatments like stimulants or therapy can join. They must score at least 8 on the ASRS-V1.1 questionnaire for ADHD symptoms and be able to give informed consent. People with recent surgery, pregnancy, severe organ failure, cancer, macular degeneration, scalp conditions, or inability to remain still are excluded.

Inclusion Criteria

I am 18 years old or older.

The person's score on the Adult ADHD Self-Report Questionnaire (ASRS-V1.1) was 8 or higher, indicating that they have symptoms of ADHD.

I have been diagnosed with ADHD.

Exclusion Criteria

I have severe kidney, lung, heart, or liver disease.

I have another type of cancer or a disease that causes new blood vessels to form.

I can't stay still enough in a calm environment to fall asleep.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 consecutive weekly ultrasound sessions targeting the anterior cingulate

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brainsonix Pulsar 1002

Trial Overview The trial is testing the Brainsonix Pulsar 1002 device's safety and potential effectiveness in treating ADHD symptoms over a longer period. It's an open label study where everyone knows they're getting the treatment being tested.

Participant Groups

Group I: Focused Ultrasound Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-intensity ultrasound stimulation modulates cortical neurovascular coupling in an attention deficit hyperactivity disorder rat model. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Impaired Local and Long-Range Brain Connectivity and Visual Response in a Genetic Rat Model of Hyperactivity Revealed by Functional Ultrasound. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Modulation effect of non-invasive transcranial ultrasound stimulation in an ADHD rat model. [2023]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Attention deficit hyperactivity syndrome: evolution, clinical presentations, treatment]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Neurodevelopmental Disorders in the PICU Population. [2020]