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
About this trial
This is an interventional treatment trial for Essential Tremor
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
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
NCT ID
NCT04727658
First Posted
January 11, 2021
Last Updated
January 22, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
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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