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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of study (average time 8-weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study (average time 8-weeks)
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My doctor has confirmed my tremor.I am currently receiving treatment for cancer.I have a scalp rash or open wounds on my scalp.You agree to follow the rules and guidelines of the study.My doctor has confirmed my shaking or tremor.I am 90 years old or younger.My doctor has confirmed I have Parkinson's Disease.I have macular degeneration.I can't stay still enough to fall asleep in a calm environment.I am unable to understand and give consent for treatment.I am 90 years old or younger with Essential Tremor.I am not willing to use two forms of birth control.My doctor has confirmed I have Parkinson's Disease.You have a very serious illness that is in its late stages.I am 18 years old or older with Parkinson's Disease.I have a condition that involves abnormal growth of blood vessels.I am 90 years old or younger with Parkinson's Disease.I am 18 years old or older.I am a male and unwilling to use double-barrier contraception.I am between 18 and 90 years old.You must be able to understand and communicate effectively in English.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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