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

Primary Purpose

Essential Tremor, Parkinsonian Disorders

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiosurgical thalamotomy on GammaKnife
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Radiosurgical thalamotomy on GammaKnife

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    Tremor improvement
    It will be measured by decrease in FTM scale score for contralateral upper limb

    Full Information

    First Posted
    January 11, 2021
    Last Updated
    January 22, 2021
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04727658
    Brief Title
    Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)
    Acronym
    FRACTHAL
    Official Title
    Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    March 2026 (Anticipated)
    Study Completion Date
    March 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Essential Tremor, Parkinsonian Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiosurgical thalamotomy on GammaKnife
    Arm Type
    Experimental
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiosurgical thalamotomy on GammaKnife
    Intervention Description
    fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )
    Primary Outcome Measure Information:
    Title
    Treatment toxicity
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Treatment accuracy
    Description
    Measurement of the shift between the position of the treatment isocenter and the position of the hypersignal center visible on the injected MRI
    Time Frame
    At 6 and 12 months
    Title
    Tremor improvement
    Description
    It will be measured by decrease in FTM scale score for contralateral upper limb
    Time Frame
    At 3, 6 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cécile ORTHOLAN
    Phone
    00 377 97 98 84 20
    Email
    cecile.ortholan@chpg.mc

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no data sharing is planned

    Learn more about this trial

    Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

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