What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include cholinesterase inhibitors, dopaminergic therapies, and non-invasive brain stimulation methods like transcranial magnetic stimulation (TMS). Cholinesterase inhibitors, such as rivastigmine and donepezil, can cause side effects like nausea, worsened tremor, and vomiting. Dopaminergic therapies, including levodopa and dopamine agonists like pramipexole and ropinirole, may lead to nausea, dizziness, hallucinations, and dyskinesia. TMS is generally considered safe, with rare occurrences of seizures and minimal side effects like headaches. These treatments aim to manage symptoms but come with varying degrees of side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on dopaminergic therapies such as levodopa, dopamine agonists, and MAO-B inhibitors. While Transcranial Ultrasound is a non-invasive brain stimulation technique currently under study, a similar non-invasive method, repetitive transcranial magnetic stimulation (rTMS), has been explored for its potential benefits in PD. However, rTMS has shown mixed results in clinical trials and is not yet widely adopted as a standard treatment for PD. Other non-dopaminergic approaches and advanced therapies like deep brain stimulation (DBS) are also used but involve surgical procedures.

What other types of research exist?

Promising, novel alternatives to Transcranial Ultrasound for Parkinson's Disease patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown effectiveness in reducing symptoms in clinical trials. 2) Transcranial Direct Current Stimulation (tDCS), which has been investigated for improving motor and cognitive functions. Both methods are non-invasive and have demonstrated potential benefits in recent studies.

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Focused Ultrasound

Transcranial Focused Ultrasound for Dementia

N/A

Waitlist Available

Led By Sheldon E Jordan, M.D.

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

CDR stage of at least 0.5 (mild cognitive impairment)

Be older than 18 years old

Must not have

Subjects with major depressive disorder

Subjects unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after final ultrasound (8 weeks from baseline)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment that uses sound waves aimed at specific brain areas to help patients with memory and cognitive issues. The goal is to see if this method is safe and effective for people with mild cognitive impairment or dementia. The therapy has been shown to be effective and safe in animal models of Alzheimer's disease and vascular dementia, with previous trials indicating a tendency to suppress cognitive impairment.

Who is the study for?

This trial is for people with mild cognitive impairment or early-stage dementia, evidenced by specific brain imaging markers. Participants must be able to give informed consent and lie still in a calm environment. Those with cognitive issues due to acute illness, scalp conditions, severe physical illnesses, major depression, or vascular dementia are excluded.

What is being tested?

The study tests the safety and initial effectiveness of transcranial focused ultrasound as a treatment for neurodegenerative dementias like Alzheimer's and Parkinson's disease over an extended period.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the site of ultrasound application, headache, or temporary changes in mood or cognition due to the intervention.

Eligibility Criteria

Inclusion Criteria

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

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I have mild memory or thinking problems.

Exclusion Criteria

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

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I have been diagnosed with major depressive disorder.

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I am unable to understand and give consent for treatment.

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My cognitive issues are due to a recent illness.

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

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

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My dementia is caused by blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after final ultrasound (8 weeks from baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after final ultrasound (8 weeks from baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after final ultrasound (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.

Primary study objectives

Quick Dementia Rating Scale

Secondary study objectives

Montreal Cognitive Assessment (MoCA)

Quick Dementia Rating Scale (QDRS)

Repeatable Battery Assessment for Neuropsychological Status (RBANS)

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: TreatmentExperimental Treatment1 Intervention

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

0 / 7Eligibility 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 Parkinson's Disease (PD) include dopaminergic therapies such as levodopa, dopamine agonists, and MAO-B inhibitors, which aim to replenish or mimic dopamine to improve motor function. Levodopa is converted to dopamine in the brain, dopamine agonists stimulate dopamine receptors, and MAO-B inhibitors prevent the breakdown of dopamine. These treatments are crucial as they address the dopamine deficiency that underlies PD motor symptoms. Non-invasive brain stimulation techniques like transcranial ultrasound are being studied for their potential to modulate brain activity and improve motor symptoms by targeting specific brain regions without surgery, offering a promising alternative or adjunct to traditional dopaminergic therapies.

An Overview of Acoustic-Based Interventions to Improve Motor Symptoms in Parkinson's Disease.Brain dopamine and kinematics of graphomotor functions.