Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

Centre Hospitalier Universitaire de Nice

Status and phase

Active, not recruiting

Phase 2

Conditions

Parkinsonian Disorders

Essential Tremor

Treatments

Radiation: Radiosurgical thalamotomy on GammaKnife

Study type

Interventional

Funder types

Other

Identifiers

NCT04727658

18-01

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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