Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jan 22, 2021

Keywords

ClinConnect Summary

The FRACTHAL clinical trial is studying a new treatment for patients suffering from essential tremor and Parkinsonian disorders, which are conditions that cause uncontrollable shaking. This trial aims to test a method called fractional radiosurgical thalamotomy using a linear accelerator, a type of machine that delivers precise radiation therapy. The goal is to see if this method is safe and effective, especially since it does not require invasive procedures that can be difficult for older patients.

To participate in this trial, individuals must be at least 18 years old and have significant tremors that affect their daily life. They should either cannot have or do not want a different treatment known as deep brain stimulation. Participants will be closely monitored throughout the study, and the treatment will be divided into three sessions to help protect surrounding healthy tissue while still targeting the tremors effectively. It’s important to know that this trial is not yet recruiting participants, but it could provide a new option for those who struggle with tremors and are looking for effective treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • brain irradiation history ;
• • contraindication or inability to perform injected MRI ;
• • life expectancy \<12 months ;
• • claustrophobic patient who cannot stand the radiotherapy mask ;
• • abnormal anatomy of the thalamic region ;
• • treatment with a trial drug within 30 days of entering the study ;
• • 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