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Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)
Sponsor: Centre Hospitalier Universitaire de Nice
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.
Official title: Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2021-07-01
Completion Date
2027-03
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
Radiosurgical thalamotomy on GammaKnife
fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )
Locations (1)
Centre Hospitalier Princesse Grace
Monaco, Monaco