Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL) (FRACTHAL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinsonian Disorders; Essential Tremor
• Intervention / Treatment: Radiation: Radiosurgical thalamotomy on GammaKnife

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cécile ORTHOLAN; Phone Number: 00 377 97 98 84 20; Email: cecile.ortholan@chpg.mc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiosurgical thalamotomy on GammaKnife	Radiation: Radiosurgical thalamotomy on GammaKnife; fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Tremor improvement	It will be measured by decrease in FTM scale score for contralateral upper limb	At 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2026
• Study Completion (Anticipated): March 1, 2027

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Dyskinesias; Parkinsonian Disorders; Tremor; Essential Tremor
• Other Study ID Numbers: 18-01 (National Center for Advancing Translational Sciences (NCATS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no data sharing is planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No