LIFUS Offline for Orthostatic Tremor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Toronto Western Hospital, Toronto, Canada
Orthostatic Tremor+1 More
LIFUS Offline - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Primary orthostatic tremor (POT) is a rare movement disorder that is manifested through high frequency tremor of weight bearing limbs. This is often accompanied by a debilitating sensation of falling. POT has been linked to abnormal activity of the cerebellum, a structure deep within the brain. However, established non-invasive brain stimulation techniques can only modulate brain activity and plasticity in superficial brain areas with low spatial resolution. This limits their efficacy when targeting the cerebellum. In contrast, low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. Therefore, LIFUS is well suited to modulate cerebellar activity and has the potential to be a superior technique for the management of POT. This study will investigate the effectiveness of MRI-guided bilateral cerebellar LIFUS stimulation for the treatment of POT and evaluate the underlying changes in brain circuits caused by the stimulation. Comparisons between symptoms and connectivity of brain circuits pre- and post-stimulation will be conducted to assess the effects of cerebellar LIFUS. The effects of real stimulation will also be compared to sham stimulation. This study is the first to apply LIFUS for neuromodulation in POT and will be critical in developing therapeutic LIFUS protocols.

Eligible Conditions

  • Orthostatic Tremor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Orthostatic Tremor

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 2 Years

2 Years
Assessment of body posture
Orthostatic Tremor Severity and Disability Scale (OT-10)
Power spectral analysis
Standing time
Tremor frequency

Trial Safety

Safety Progress

1 of 3

Other trials for Orthostatic Tremor

Trial Design

1 Treatment Group

Low Intensity Focused ultrasound
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: LIFUS Offline · No Placebo Group · N/A

Low Intensity Focused ultrasoundExperimental Group · 3 Interventions: LIFUS Offline, LIFUS Online Sham, LIFUS Online Real · Intervention Types: Device, Device, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Toronto Western Hospital · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2011First Recorded Clinical Trial
1 TrialsResearching Orthostatic Tremor
200 CompletedClinical Trials

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,351 Previous Clinical Trials
471,618 Total Patients Enrolled
National Organization for Rare DisordersOTHER
3 Previous Clinical Trials
10,061 Total Patients Enrolled
Robert Chen, MBBSPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.