Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)
Reason given: The treatment at hand was not efficient enough.
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Trial code
- NCT04727658
- Record updated
- 26 May 2026
- Original description
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.Read full original descriptionShow less
Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
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.
Inclusion: patient with disabling essential tremor, dystonic and / or parkinsonian in one or more limbs superiors ; patient contraindicated or refusing deep brain stimulation ; patient ≥ 18 years old,; women of childbearing potential must take effective contraception ; signature of informed consent ; p- atients who benefited from contralateral thalami c stimulation can be included in the study.
Exclusion: brain irradiation history ; claustrophobic patient who cannot stand the radiotherapy mask ; treatment with a trial drug within 30 days of entering the study ; contraindication or inability to perform injected MRI ; life expectancy <12 months ; abnormal anatomy of the thalamic region ; presence of medical, psychological, social or geographic factors likely to modify the patient's compliance with the protocol under study or the monitoring or signing of the consent.