Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07049003
Phase
PHASE1
Status
Recruiting
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Conditions

  • Essential Tremor
  • Tremor

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation — DEVICE
    Deep Brain Stimulation of the Deep Cerebellar Nuclei

Study Details

This objective of this study is to document the safety and feasibility of electrical stimulation of the deep cerebellar nuclei for refractory tremor using the Medtronic Percept RC Deep Brain Stimulation System. The population will consist of patients that have either failed a prior intervention (Vim DBS or HIFU thalamotomy) or determined to not be suitable candidates for Vim DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor. Those patients with a previous intervention, must have a prior diagnosis of ET, cerebellar outflow tremor, or MS-related tremor. Subjects without a previous intervention must have a diagnosis of cerebellar outflow tremor or MS-related tremor.

Key Dates

Start date
May 19, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Refractory Tremor
    Medtronic Percept RC DBS System

Primary Outcome Measure

The incidence and nature of treatment-related adverse events [ Time Frame: From DBS Implant Surgery through study completion, an average of 17 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Jeffrey Negrey, MA
[email protected]
216-316-6896

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By research site
Cleveland Clinic· Cleveland, OH

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