Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL) (FRACTHAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04727658|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2021
Last Update Posted : January 27, 2021
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|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)|
|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|
|Experimental: Radiosurgical thalamotomy on GammaKnife||
Radiation: Radiosurgical thalamotomy on GammaKnife
fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )
- 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.
- 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
- Tremor improvement [ Time Frame: At 3, 6 and 12 months ]It will be measured by decrease in FTM scale score for contralateral upper limb
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
|Contact: Cécile ORTHOLAN||00 377 97 98 84 firstname.lastname@example.org|