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Ultrasound Therapy
Sham, then Active for Parkinson's Disease (LIFUP Trial)
N/A
Recruiting
Led By Taylor P Kuhn, Ph.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-lifup and post-lifup at day 1 and day 15
Awards & highlights
LIFUP Trial Summary
This trial will test a new, non-invasive therapy that could improve Parkinson's Disease symptoms. It could be the first step towards a medication-free treatment.
Who is the study for?
This trial is for right-handed individuals aged 18-65 who have been diagnosed with Parkinson's Disease and are fluent in English. It excludes those with metal implants, other neurological or psychiatric diagnoses besides Parkinson's, non-English speakers, and left-handed people.Check my eligibility
What is being tested?
The study is examining the use of Low Intensity Focused Ultrasound Pulsation (LIFUP) to treat motor symptoms in Parkinson’s Disease. Participants will receive either active LIFUP treatment or a sham (placebo) version to assess its effects on brain activity and motor function.See study design
What are the potential side effects?
Since LIFUP is a non-invasive technique that does not involve medication, side effects may be minimal. However, as it is a new method, potential side effects related to ultrasound exposure on specific brain areas will be closely monitored.
LIFUP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-lifup and post-lifup at day 1 and day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-lifup and post-lifup at day 1 and day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motor Assessment 1: Finger Tapping
Motor Assessment 2: 9-Hole Pegboard Dexterity Test
Motor Assessment 3: Unified Parkinson Disease Rating Scale (UPDRS) Section 3
Secondary outcome measures
BOLD fMRI Signal in Internal Globus Pallidus
Perfusion throughout Brain
LIFUP Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham, then ActiveExperimental Treatment2 Interventions
Sham low intensity focused ultrasound pulsation (LIFUP) will be administered while participants are in the MRI scanner. Then, 2 weeks later, active LIFUP will be administered to the internal globus pallidus.
Group II: Active, then ShamExperimental Treatment2 Interventions
Active Low intensity focused ultrasound pulsation (LIFUP) will be administered to the internal globus pallidus while participants are in the MRI scanner. Then, 2 weeks later, sham LIFUP will be administered.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,238 Total Patients Enrolled
Taylor P Kuhn, Ph.D.Principal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fluent in English.I am between 18 and 65 years old.I have a neurological or psychiatric condition that is not Parkinson's.I have metal implants in my body.I am right-handed.I have been diagnosed with Parkinson's disease.I am left-handed.
Research Study Groups:
This trial has the following groups:- Group 1: Sham, then Active
- Group 2: Active, then Sham
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.
Are individuals being accepted into this research study at present?
"Checking the clinicaltrials.gov listing, it appears that this study is still recruiting participants; posted on June 15th 2022 and last modified March 13th 2023."
Answered by AI
Is eligibility for this experiment limited to those over 18 years of age?
"According to the requirements outlined in the trial protocols, individuals must be of legal age (minimum 18) and under 65 years old to participate."
Answered by AI
Who is qualified to participate in this experiment?
"This clinical trial seeks 30 participants with a Parkinson's disease diagnosis and of age 18-65. Eligibility criteria is strictly limited to those conditions."
Answered by AI
How many volunteers have signed up for the trial thus far?
"Affirmative. Per the information published on clinicaltrials.gov, this investigation is actively seeking subjects for participation. It was posted to the website on June 15th 2022 and last updated March 13th 2023; 30 participants are needed from a single site."
Answered by AI
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