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| Name | Class |
|---|---|
| Raynor Cerebellum Project | UNKNOWN |
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractory Tremor | Experimental | Medtronic Percept RC DBS System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Deep Brain Stimulation of the Deep Cerebellar Nuclei |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and nature of treatment-related adverse events | The accumulation of adverse events across all subjects | From DBS Implant Surgery through study completion, an average of 17 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fahn Tolosa Marin Tremor Rating Scale | An objective measurement of the severity of tremor. A 32-part questionnaire that evaluates tremor severity by assigning a numerical value of 0-4 to the answers for 32 questions. Numerical values are added together for a total score. A higher score represents a more severe tremor than a lower score. | From DBS Implant Surgery through study completion, an average of 17 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Negrey, MA | Contact | 2163166896 | negreyj2@ccf.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D014202 | Tremor |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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All subjects will receive open label deep brain stimulation implantation of the deep cerebellar nuclei
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| DBS-evoked potentials | The prevalence and strength of markers of electrophysiological activity across the cerebellothalamocorticomuscular (CTCM) network at rest and during tremor-eliciting motor behaviors. | From DBS Implant Surgery through study completion, an average of 17 months |
| 4-8 HZ (theta) tremor related oscillations | Examination of how the DN and VIM DBS (when present) modulate oscillatory activity and coupling across the CTCM circuit in relation to improvements in tremor control. A 4-8Hz (theta) tremor-related oscillation is observed consistently in the VIM during motor activity, which parallels the activity-dependent appearance of tremor in patients with ET. | From DBS Implant Surgery through study completion, an average of 17 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |