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Focused Ultrasound

Transcranial Ultrasound for Tremor

Phase < 1
Recruiting
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
At most 90 years of age
Must not have
Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
Any active cancer or chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study (average time 8-weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial is to see if transcranial ultrasound is a tolerable and effective treatment for tremor in people with Parkinson's or Essential Tremor.

Who is the study for?
This trial is for adults aged 18-90 with tremors due to Parkinson's Disease or Essential Tremor. Participants must understand English, be able to follow the study protocol, and have their condition confirmed by a physician. Pregnant women, individuals with active cancer or certain illnesses, those unable to lay still for treatment, or with scalp conditions are excluded.
What is being tested?
The study is testing transcranial ultrasound as a treatment for tremors in patients with Parkinson's Disease or Essential Tremor. It's an open label Phase I trial aimed at assessing the safety and potential effectiveness of this non-invasive technique over a longer term.
What are the potential side effects?
As it’s an early phase trial focusing on tolerability and effectiveness of focused ultrasound for treating tremors, specific side effects are not detailed but may include discomfort at the site of treatment or headache.

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.
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I am 90 years old or younger.
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My doctor has confirmed I have Parkinson's Disease.
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I am 90 years old or younger with Essential Tremor.
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My doctor has confirmed I have Parkinson's Disease.
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I am 18 years old or older with Parkinson's Disease.
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I am 90 years old or younger with Parkinson's Disease.
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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 a scalp rash or open wounds on my scalp.
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I am currently receiving treatment for cancer.
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I have macular degeneration.
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I can't stay still enough to fall asleep in a calm environment.
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I am unable to understand and give consent for treatment.
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I am not willing to use two forms of birth control.
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I have a condition that involves abnormal growth of blood vessels.
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I am a male and unwilling to use double-barrier contraception.
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I am between 18 and 90 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study (average time 8-weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study (average time 8-weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oils, Volatile
Secondary study objectives
9 Hole Pegboard Task (9 HPT)
Parkinson's Activities of Daily Living Scale (PAD-L)

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: ExperimentalExperimental Treatment1 Intervention
Participants will undergo ten to thirty minutes of transcranial ultrasound treatment. The sanitation device will be aimed at the hypothalamus. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Focused Ultrasound
2012
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Neurological Associates of West Los AngelesLead Sponsor
25 Previous Clinical Trials
3,910 Total Patients Enrolled
Sheldon Jordan, MDPrincipal InvestigatorThe Regenesis Project
12 Previous Clinical Trials
2,540 Total Patients Enrolled

Media Library

Transcranial Ultrasound (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05475340 — Phase < 1
Tremor Research Study Groups: Experimental
Tremor Clinical Trial 2023: Transcranial Ultrasound Highlights & Side Effects. Trial Name: NCT05475340 — Phase < 1
Transcranial Ultrasound (Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05475340 — Phase < 1
~15 spots leftby Oct 2025
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