Focused Ultrasound for ADHD

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment, transcranial ultrasound, for people with ADHD. The researchers aim to determine if this focused ultrasound can provide a long-term solution for those who haven't succeeded with standard treatments like medication or therapy. Participants will undergo a brief ultrasound session targeting a specific area of the brain. Ideal candidates are adults diagnosed with ADHD who haven't found relief from traditional methods.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for 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.

What prior data suggests that this technique is safe for ADHD?

Research has shown that the Brainsonix Pulsar 1002 ultrasound device has been tested for safety in people. One study used the device to deliver low-intensity focused ultrasound to assess its safety for treating anxiety and depression, suggesting potential safety for other brain-related conditions as well.

Another study employed this ultrasound device with MRI guidance to evaluate its safety, and no major negative effects emerged.

Overall, these studies indicate that the Brainsonix Pulsar 1002 is generally well-tolerated in people. While this does not guarantee safety for everyone, it provides a good starting point for considering its use in treating ADHD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about focused ultrasound for ADHD because it offers a non-invasive approach that directly targets brain activity. Unlike traditional treatments such as medication or behavioral therapy, this method uses sound waves to focus on the anterior cingulate, a key area involved in attention and impulse control. The Brainsonix Pulsar 1002 device ensures precise targeting, potentially leading to quicker and more accurate results. This innovative treatment could provide a new option for those who prefer to avoid medication or who haven't found success with existing therapies.

What evidence suggests that this ultrasound technique is effective for ADHD?

Research has shown that focused ultrasound, such as the Brainsonix Pulsar 1002, might benefit people with ADHD. This trial will use the Brainsonix Pulsar 1002 to target specific brain areas that control attention and behavior. Studies have found that this method could enhance brain function over time. The Brainsonix Pulsar 1002 has undergone testing on several patients and is considered safe. While still under study, this approach aims to offer a non-invasive option for those with ADHD. ^{2 3 4 6 7}

Who Is on the Research Team?

Sheldon Jordan, MD

Principal Investigator

Neurological Associates of West Los Angeles

Are You a Good Fit for This Trial?

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

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.

Standard treatments like stimulants or therapy haven't improved my symptoms.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-6-2020-64cdd

Focused Ultrasound for ADHD · Info for Participants 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11219564/

Current state of clinical ultrasound neuromodulation - PMC Non-invasive TUS neuromodulation has been investigated using different techniques, starting with unfocussed diagnostic ultrasound systems ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0896627323001228

and long-term improvement and monitoring of brain function The BrainSonix Pulsar 1002 system was used in eight patients, demonstrating that intensities up to an ISPTA that was 8-fold higher than the ...

4. teams.semel.ucla.edu teams.semel.ucla.edu/sites/default/files/users/user-739/bxpulsar1002_user_manual_053019.pdf

BrainSonix Corp. The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain, and to be safe for ...

5. fusfoundation.org fusfoundation.org/posts/clinical-trial-investigates-low-intensity-focused-ultrasound-for-depression/

Clinical Trial Investigates Low-Intensity ... A clinical trial is investigating the safety and feasibility of using low-intensity focused ultrasound to address anxiety and depression.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11591555/

Preliminary Examination of the Effects of Focused ... As such, this study aimed to explore the safety of the BrainSonix BX Pulsar 1002 Focused Ultrasonic Pulsation Device at a stimulation of I ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34198105/

Safety of focused ultrasound neuromodulation in humans ... Using the BrainSonix Pulsar 1002, tFUS was delivered under MR guidance, using the Siemens Magnetom 3T Prisma scanner. Neuropsychological changes were ...