NCT04727658

Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor
• Parkinsonian Disorders

Interventions

Type	Name	Description
RADIATION	Radiosurgical thalamotomy on GammaKnife	fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )

Timeline

• Start date: 2021-07-01
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2021-01-27
• Last updated: 2025-12-08

Locations

1 site across 1 country: Monaco