LIFUS for Orthostatic Tremor

(LIFUS-POT Trial)

Overseen By Julian Kwok

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Antipsychotics, Marijuana, Recreational drugs

Disqualifiers: Stroke, Seizure, Dementia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 sessions

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new technique called low intensity focused ultrasound (LIFUS) to help people with primary orthostatic tremor (POT), a condition causing leg tremors when standing. LIFUS uses sound waves to precisely target and stimulate deep brain areas, aiming to reduce symptoms and improve brain function. The study will compare the effects of real and fake stimulation to see how well LIFUS works. Focused ultrasound can stimulate specific tissue points and has been studied for its effects on blood flow and coldness in fingers and toes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antipsychotics, marijuana, or other recreational drugs that affect the nervous system.

How is the LIFUS Online Real treatment different from other treatments for orthostatic tremor?

LIFUS Online Real is unique because it likely involves a novel approach using focused ultrasound technology, which is different from traditional drug treatments like levodopa or perampanel that have been tried for orthostatic tremor. This treatment might offer a non-invasive option, potentially targeting the tremor's source directly without the need for medication. ^{1 2 3 4 5}

Research Team

Robert Chen, MBBS

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with orthostatic tremor.

Exclusion Criteria

I have had a stroke or seizure in the past.

I am currently using antipsychotics, marijuana, or other recreational drugs.

Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI-guided bilateral cerebellar LIFUS stimulation to assess its effects on POT symptoms and brain connectivity

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• LIFUS Offline
• LIFUS Online Real
• LIFUS Online Sham

Trial Overview 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.

Participant Groups

Group I: Low Intensity Focused ultrasound Experimental Treatment 3 Interventions

NeuroFUS device stimulation with 4 channel transducer Stimulation target = Cerebellum

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

National Organization for Rare Disorders

Collaborator

Trials

5

Recruited

10,600+

References

1. Belgium pubmed.ncbi.nlm.nih.gov

Primary orthostatic tremor: analysis of three cases. [2004]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life Is Severely Affected in Primary Orthostatic Tremor. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Levodopa may improve orthostatic tremor: case report and trial of treatment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Orthostatic tremor: Clinical, electrophysiologic, and treatment findings in 184 patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Primary Orthostatic Tremor: Experience of Perampanel Use in 20 Patients. [2021]