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NCT06325852

Directional Bilateral Thalamic Patterned Stimulation (Chronos)

Recruiting now NA Last updated 4 November 2024
What this trial tests

NA trial testing DBS programing in Essential Tremor in 15 participants. Currently enrolling.

Timeline
16 July 2024
Primary endpoint
1 April 2026
1 January 2027

Quick facts

Lead sponsorAlfonso Fasano
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment15
Start date16 July 2024
Primary completion1 April 2026
Estimated completion1 January 2027
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Alfonso Fasano

Who can join

Adults 18 to 85, any sex, with Essential Tremor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Essential Tremor

Currently open trials in the same condition.

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Data sources for this page

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