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Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL) — FRACTHAL  

Essential Tremor Clinical Trial

Official title:
Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study

Clinical Trial Summary

Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. In addition, fitting the invasive frame and the need to travel to GammKnife centers often limit access to treatment in this population of elderly patients. Linear accelerators have greatly improved their precision, now reaching that of GammaKnife. A possible alternative is therefore to treat patients on linear accelerators, without an invasive frame. The objective of the FRACTHAL study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator. The main hypothesis of the FRACTHAL study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04727658
Study type Interventional
Source Centre Hospitalier Universitaire de Nice
Contact Cécile ORTHOLAN
Phone 00 377 97 98 84 20
Email cecile.ortholan@chpg.mc
Status Not yet recruiting
Phase Phase 2
Start date March 2021
Completion date March 2027
View Details
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