Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04727658

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

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 )

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

Primary Outcome Measures

Treatment toxicity [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

Treatment accuracy [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 [At 3, 6 and 12 months]
It will be measured by decrease in FTM scale score for contralateral upper limb

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT04727658

Other Study ID Numbers:

18-01

First Posted:

Jan 27, 2021

Last Update Posted:

Jan 27, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tremor

Essential Tremor

Parkinsonian Disorders

Study Results

No Results Posted as of Jan 27, 2021