Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325852
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-13
Brief Title:
Directional Bilateral Thalamic Patterned Stimulation Chronos
Sponsor:
Alfonso Fasano
Organization:
University of Toronto
Study Overview
Official Title:
Directional Bilateral Thalamic Patterned Stimulation in Individuals With Essential Tremor
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Cartesia 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None