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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study (average time 8-weeks)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am 90 years old or younger with Essential Tremor.
Select...
My doctor has confirmed I have Parkinson's Disease.
Select...
I am 18 years old or older with Parkinson's Disease.
Select...
I am 90 years old or younger with Parkinson's Disease.
Select...
I am 18 years old or older.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oils, Volatile
Secondary outcome measures
9 Hole Pegboard Task (9 HPT)
Parkinson's Activities of Daily Living Scale (PAD-L)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial currently enlisting participants?
"Per the data held on clinicaltrials.gov, this investigation is seeking volunteers; it was first made available to potential enrollees on July 13th 2022 and has since been revised as of July 25th 2022."
Answered by AI
Does this clinical trial accept participants older than 18 years old?
"According to the prerequisites for this research, potential participants must be of legal age (18) or older and not exceed 90 years old."
Answered by AI
Is it possible to enroll in this experiment?
"This medical trial seeks 50 participants with a diagnosable case of Parkinson's disease, who must be between the ages 18 and 90. To qualify for this study, candidates should possess English fluency, have their tremor symptomology verified by a physician, commit to fulfilling all requirements of the protocol, and hold an official diagnosis from their doctor."
Answered by AI
How many participants is this experiment capable of accommodating?
"Affirmative. Clinicaltrials.gov reveals that this investigation is currently recruiting patients, with the original post being made on July 13th 2022 and subsequently updated on July 25th of the same year. The study aims to enroll 50 people from a single site."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Florida
Other
California
How old are they?
18 - 65
What site did they apply to?
Neurological Associates of West Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How frequent is the travel to LA?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Neurological Associates of West Los Angeles: < 24 hours
Average response time
- < 2 Days
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