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NCT06325852
Directional Bilateral Thalamic Patterned Stimulation (Chronos)
NA trial testing DBS programing in Essential Tremor in 15 participants. Currently enrolling.
1 April 2026
Quick facts
| Lead sponsor | Alfonso Fasano |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 16 July 2024 |
| Primary completion | 1 April 2026 |
| Estimated completion | 1 January 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- DBS programing
Conditions studied
- Essential Tremor — all drugs for Essential Tremor →
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.
Verify or expand the search:
- PubMed search for NCT06325852
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Essential Tremor
Currently open trials in the same condition.
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07172295 — Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With R · NA · recruiting
- NCT07016425 — Temporal Interference for Essential Tremor · NA · recruiting
- NCT07049003 — Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor · Phase 1 · recruiting
- NCT06428526 — Impact of Sensory Electrical Stimulation on Sensation and Tremor · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06325852 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alfonso Fasano
- Last refreshed: 4 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06325852.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing