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Modulating Cerebellar Activity With Low-intensity Focused Ultrasound Stimulation for Primary Orthostatic Tremor

NCT05547620 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-24

No results posted yet for this 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.

Conditions

  • Orthostatic Tremor

Interventions

DEVICE

LIFUS Online Real

Stimulation using NeuroFUS device while standing

DEVICE

LIFUS Online Sham

Stimulation using NeuroFUS device while standing

DEVICE

LIFUS Offline

Stimulation using NeuroFUS device prior to standing

Sponsors & Collaborators

  • National Organization for Rare Disorders

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Robert Chen, MBBS · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2027-01-31
Completion
2027-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05547620 on ClinicalTrials.gov