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LIFUS for Orthostatic Tremor (LIFUS-POT Trial)
N/A
Recruiting
Led By Robert Chen, MBBS
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of orthostatic tremor
18-90 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
LIFUS-POT Trial Summary
This trial is studying a new brain stimulation technique called low intensity focused ultrasound (LIFUS) to see if it can help people with primary orthostatic tremor (POT).
Who is the study for?
This trial is for individuals aged 18-90 with a confirmed diagnosis of orthostatic tremor. It's not suitable for those with brain implants, previous movement disorder surgeries, pregnant women, severe depression or psychiatric disorders, cognitive impairment (MoCA score <22), pacemakers/ICDs, metal in the body contraindicated by MRI/TMS, drug use affecting the nervous system, major hand/wrist/limb diseases or systemic illness/infection.Check my eligibility
What is being tested?
The study tests low intensity focused ultrasound (LIFUS) to modulate cerebellar activity in patients with primary orthostatic tremor. Participants will receive either real LIFUS stimulation while connected to an MRI machine or sham (fake) treatment to compare effects on their condition and brain circuitry changes.See study design
What are the potential side effects?
As LIFUS is non-invasive and focuses on deep brain structures without surgery or drugs, side effects are expected to be minimal. However, potential risks may include discomfort at the stimulation site or transient headaches.
LIFUS-POT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with orthostatic tremor.
Select...
I am between 18 and 90 years old.
LIFUS-POT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Orthostatic Tremor Severity and Disability Scale (OT-10)
Power spectral analysis
Tremor
Secondary outcome measures
Assessment of body posture
Standing time
LIFUS-POT Trial Design
1Treatment groups
Experimental Treatment
Group I: Low Intensity Focused ultrasoundExperimental Treatment3 Interventions
NeuroFUS device stimulation with 4 channel transducer Stimulation target = Cerebellum
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,978 Total Patients Enrolled
National Organization for Rare DisordersOTHER
4 Previous Clinical Trials
10,561 Total Patients Enrolled
Robert Chen, MBBSPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke or seizure in the past.I am currently using antipsychotics, marijuana, or other recreational drugs.You have an implant or device in your head.I have had surgery for my movement disorder, like DBS.I have been diagnosed with orthostatic tremor.I am between 18 and 90 years old.You scored less than 22 on the Montreal Cognitive Assessment (MoCA).I do not have any major illnesses or infections.You have metal in your body that could be unsafe during a TMS or MRI.I do not have major diseases affecting my hands, wrists, or limbs.You have dementia along with other health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Low Intensity Focused ultrasound
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 study actively searching for participants at present?
"According to the clinicaltrials.gov, this study is currently recruiting participants for its trial and has been doing so since it was released on March 8th 2021 with the most recent update being made on September 27th 2022."
Answered by AI
Is this research endeavor recruiting participants aged 70 or older?
"Eligibility for this trial is restricted to those aged 18-90."
Answered by AI
Is my participation permissible in this research trial?
"This trial seeks to recruit 15 patients who suffer from orthostatic tremor, and are between 18-90 years of age."
Answered by AI
How many participants are being included in this trial?
"Affirmative, the information on clinicaltrials.gov verifies that this study is actively recruiting patients. It was initially posted on March 8th 2021 and recently updated on September 27th 2022. This trial hopes to enrol 15 participants at a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
How old are they?
65+
What site did they apply to?
Toronto Western Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
This disease is not well understood…need for more research and clinical trials.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
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