What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications such as methylphenidate and mixed amphetamine salts, which can cause side effects like insomnia, decreased appetite, weight loss, increased heart rate, and potential for substance abuse. Non-pharmacological treatments like cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) generally have minimal side effects but may include emotional discomfort or increased anxiety during sessions. Neurofeedback is considered safe with minimal side effects, though headaches can occur. Transcranial magnetic stimulation (TMS) is also generally safe but can cause mild side effects such as headaches and, rarely, seizures.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate and mixed amphetamine salts, as well as non-stimulants like atomoxetine, clonidine, and guanfacine. These medications have been shown to improve attention and reduce hyperactivity and impulsivity in individuals with ADHD. While non-invasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) are being explored for ADHD treatment, they are not yet FDA-approved. Transcranial ultrasound, another non-invasive technique, is currently under investigation for its potential effectiveness in modulating brain activity in ADHD patients.

What other types of research exist?

Promising novel alternatives to Transcranial Ultrasound for ADHD treatment include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving inattention in adults with ADHD, and 2) Auditory Noise Exposure, which has been studied for its effects on cognitive task performance in children with ADHD. Both therapies are emerging as potential non-pharmacological treatments for ADHD.

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Ultrasound Therapy

Focused Ultrasound for ADHD

N/A

Waitlist Available

Led By Sheldon Jordan, MD

Research Sponsored by Neurological Associates of West Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be between 18 and 65 years old

Must not have

Advanced kidney, pulmonary, cardiac or liver failure

Any other neoplastic illness or illness characterized by neovascularity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post final treatment (8 weeks from baseline)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of transcranial ultrasound treatment may include discomfort at the site of application or headaches due to sound waves affecting brain tissue; however specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have a scalp rash or open wounds on my scalp.

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I have macular degeneration.

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I am unable to understand and give consent for the trial.

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I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post final treatment (8 weeks from baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post final treatment (8 weeks from baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post final treatment (8 weeks from baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Adult ADHD Self-Report Scale (ASRS-v1.1)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Focused UltrasoundExperimental Treatment1 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include stimulant medications, non-pharmacological therapies, and experimental treatments like transcranial ultrasound. Stimulant medications, such as methylphenidate and amphetamines, increase the levels of dopamine and norepinephrine in the brain, which helps improve attention and reduce impulsivity and hyperactivity. Non-pharmacological therapies, such as cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), focus on developing coping strategies, improving organizational skills, and enhancing emotional regulation. Experimental treatments like transcranial ultrasound aim to modulate brain activity through sound waves, potentially offering a non-invasive alternative to traditional medications. These treatments are crucial for ADHD patients as they provide multiple options to manage symptoms, improve daily functioning, and enhance overall quality of life.

Enhancing attention in neurodegenerative diseases: current therapies and future directions.[Noninvasive cerebral stimulation for treatment of ADHD: A review of the literature].Comparing Auditory Noise Treatment with Stimulant Medication on Cognitive Task Performance in Children with Attention Deficit Hyperactivity Disorder: Results from a Pilot Study.