What side effects are associated with this type of intervention?

Low Intensity Focused Ultrasound (LIFUS) is a novel non-invasive brain stimulation technique being studied for its potential to modulate cerebellar activity with high spatial focality. While specific side effects of LIFUS are not detailed in the provided context, similar non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS), have shown modest effectiveness with generally safe short-term use. Common side effects of these techniques may include mild discomfort at the stimulation site, headaches, and transient changes in mood or cognition. Larger trials are needed to fully understand the safety and efficacy of LIFUS for Orthostatic Tremor.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Primary Orthostatic Tremor (POT) that are similar to Low Intensity Focused Ultrasound (LIFUS). LIFUS is a novel technique being studied for its potential to modulate cerebellar activity with high spatial focality, which could be beneficial for managing POT. Current treatments for POT are generally symptomatic and may include medications like clonazepam, gabapentin, or propranolol, but these do not specifically target cerebellar activity as LIFUS aims to do.

What other types of research exist?

Promising alternatives to LIFUS for Orthostatic Tremor patients include Transcranial Magnetic Stimulation (TMS) and Transcutaneous Electrical Nerve Stimulation (TENS). TMS has shown potential in modulating brain activity and reducing symptoms in various neurological conditions. TENS, while typically used for pain management, is being explored for its neuromodulatory effects in movement disorders. Both techniques offer non-invasive options with growing evidence of efficacy.

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Procedure

LIFUS for Orthostatic Tremor (LIFUS-POT Trial)

Q: What is the mechanism of action of this treatment?

Orthostatic Tremor (OT) is often linked to abnormal cerebellar activity. Low Intensity Focused Ultrasound (LIFUS) is a novel treatment that modulates cerebellar activity with high spatial precision, potentially offering superior management of OT symptoms. LIFUS works by targeting deep brain structures like the cerebellum, which are involved in motor control and coordination, thereby reducing tremor severity. This is particularly important for OT patients as it addresses the root cause of their symptoms with minimal invasiveness. Other treatments, such as transcranial magnetic stimulation (TMS), also aim to modulate brain activity but are less precise and effective in reaching deeper brain areas like the cerebellum. Understanding these mechanisms helps in selecting the most effective treatment options for managing OT.

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

Must not have

History of stroke or seizure

Is on antipsychotics, marijuana, or other recreational drugs that affect the nervous system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with orthostatic tremor.

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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or seizure in the past.

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

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I have had surgery for my movement disorder, like DBS.

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I do not have any major illnesses or infections.

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I do not have major diseases affecting my hands, wrists, or limbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Orthostatic Tremor Severity and Disability Scale (OT-10)

Power spectral analysis

Tremor

Secondary study objectives

Assessment of body posture

Standing time

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: Low Intensity Focused ultrasoundExperimental Treatment3 Interventions

NeuroFUS device stimulation with 4 channel transducer Stimulation target = Cerebellum

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Orthostatic Tremor (OT) is often linked to abnormal cerebellar activity. Low Intensity Focused Ultrasound (LIFUS) is a novel treatment that modulates cerebellar activity with high spatial precision, potentially offering superior management of OT symptoms. LIFUS works by targeting deep brain structures like the cerebellum, which are involved in motor control and coordination, thereby reducing tremor severity. This is particularly important for OT patients as it addresses the root cause of their symptoms with minimal invasiveness. Other treatments, such as transcranial magnetic stimulation (TMS), also aim to modulate brain activity but are less precise and effective in reaching deeper brain areas like the cerebellum. Understanding these mechanisms helps in selecting the most effective treatment options for managing OT.

Trans-Spinal Focused Ultrasound Stimulation Selectively Modulates Descending Motor Pathway.MDS evidence-based review of treatments for essential tremor.