Status:
ACTIVE_NOT_RECRUITING
Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Essential Tremor
Parkinsonian Disorders
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 additio...
Eligibility Criteria
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 ;
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04727658
Start Date
July 1 2021
End Date
March 1 2027
Last Update
December 8 2025
Active Locations (1)
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1
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000