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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 18-90 years of age

• Confirmed diagnosis of orthostatic tremor

Locations
Other Locations
Canada
Toronto Western Hospital
Toronto
Time Frame
Start Date: 2021-03-08
Completion Date: 2026-09
Participants
Target number of participants: 15
Treatments
Experimental: Low Intensity Focused ultrasound
NeuroFUS device stimulation with 4 channel transducer Stimulation target = Cerebellum
Sponsors
Leads: University Health Network, Toronto
Collaborators: National Organization for Rare Disorders

This content was sourced from clinicaltrials.gov