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ACTIVE NOT RECRUITING
NCT04727658
PHASE2

Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

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

Interventions

RADIATION

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