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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesiaâ„¢ 8-contact Directional Leads.
Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.
Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | Experimental | 5 to 10 patients with tremor already treated with VIM-DBS but not doing well because of early or late loss of benefits will be recruited by the PI over a 6 months period. If interested, the potential participants will be screened, informed, and consented by a research coordinator. Before the replacement of their IPG (implantable pulse generator), a baseline measurement will be performed. |
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| Phase 2 | Experimental | Ten patients with ET needing DBS-VIM surgery will be recruited and will receive Boston Scientific Genus IPG bilaterally connected to Boston Scientific Cartesiaâ„¢ 8-contact Directional Leads. The programming will be done in four different settings/periods during the course of 8 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBS programing | Other | The physician will utilize the Boston Scientific Chronos Clinician Programmer (software) to make adjustments to the Deep Brain Stimulation (DBS) settings for the patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Tremor Rating Scale (Part A-B) | Range from 0-46. with 0 representing no tremor and 46 representing severe tremor. | Phase 1-Baseline |
| Tremor analysis | Using accelerometers | Phase 1-Baseline |
| Tremor Rating Scale (A-C) | Range from 0-46. with 0 representing no tremor and 46 representing severe tremor. | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Tremor analysis (meter per second squared) | Using accelerometers | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Gait speed (meter per second) | Gait Analysis | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Base of support (meter) | Gait Analysis | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Step length (meter) | Gait Analysis | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Stride length (meter) | Gait Analysis | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Movement Disorders Centre - Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Single stance time and double stance time (seconds) | Gait Analysis | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Tandem gait | Gait Analysis | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Posturography (newtons) | Using Proteokinetics Zeno System | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Quality of life in Essential Tremor Questionnaire (QUEST) | Range from 0-40, with 0 representing no tremor and 40 representing severe tremor. | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |
| Speech analysis | automated analysis pipeline in MatLab | Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 |