Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

Essential Tremor Clinical Trial

— FRACTHAL  

Official title:

Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04727658
• Other study ID #: 18-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2021
• Est. completion date: March 2027

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Cécile ORTHOLAN
• Phone: 00 377 97 98 84 20
• Email: cecile.ortholan[@]chpg.mc
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Parkinsonian Disorders
• Tremor

Intervention

Radiation:
• Radiosurgical thalamotomy on GammaKnife
fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment toxicity	The treatment will be considered toxic in the event of the appearance, within 12 months after treatment, of non-regressive toxicity of grade> 1 according to the NCI-CTCAE V5.0 scale (symptomatic neurological deficit interfering with daily activities), and that this deficit is related to the treatment.	12 months
Secondary	Treatment accuracy	Measurement of the shift between the position of the treatment isocenter and the position of the hypersignal center visible on the injected MRI	At 6 and 12 months
Secondary	Tremor improvement	It will be measured by decrease in FTM scale score for contralateral upper limb	At 3, 6 and 12 months