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

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ClinicalTrials.gov Identifier: NCT04727658
Recruitment Status : Not yet recruiting
First Posted : January 27, 2021
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Essential Tremor Parkinsonian Disorders Radiation: Radiosurgical thalamotomy on GammaKnife Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

The study will be carried out according to a design by Simon in two stages (Simon, 1989).

First step: 14 patients will be included in the study. When the 14th patient has been treated, the inclusions will be suspended for 1 year until analysis of the primary endpoint.

• Second stage: 34 additional patients will be recruited for a total of 48 patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2027

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Arms and Interventions
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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 )


Outcome Measures
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Primary Outcome Measures :
  1. Treatment toxicity [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Treatment accuracy [ Time Frame: At 6 and 12 months ]
    Measurement of the shift between the position of the treatment isocenter and the position of the hypersignal center visible on the injected MRI

  2. Tremor improvement [ Time Frame: At 3, 6 and 12 months ]
    It will be measured by decrease in FTM scale score for contralateral upper limb


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727658


Contacts
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Contact: Cécile ORTHOLAN 00 377 97 98 84 20 cecile.ortholan@chpg.mc

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04727658    
Other Study ID Numbers: 18-01
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no data sharing is planned

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Parkinsonian Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases