Linac FRACtionated Radiosurgical THALamotomie in Tremors... | NCT04727658

Studies
Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

NCT04727658

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Terminated

Last Update Posted

May 26, 2026Actual

Enrollment

9Actual

Phase

Phase 2

Conditions

Essential Tremor
Parkinsonian Disorders

Interventions

Radiosurgical thalamotomy on GammaKnife

Countries

Monaco

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The treatment at hand was not efficient enough.

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jun 20, 2024Actual

Completion Date

Jun 20, 2024Actual

First Submitted Date

Jan 11, 2021

First Submission Date that Met QC Criteria

Jan 22, 2021

First Posted Date

Jan 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiosurgical thalamotomy on GammaKnife	Experimental		Radiation: Radiosurgical thalamotomy on GammaKnife

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiosurgical thalamotomy on GammaKnife	Radiation	fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )	Radiosurgical thalamotomy on GammaKnife

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 months

Secondary Outcomes

Measure	Description	Time Frame
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	At 6 and 12 months
Tremor improvement

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Princesse Grace		Monaco		98000	Monaco

IPD Sharing Statement Module

Plan to Share IPD

Description

no data sharing is planned

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020329	Essential Tremor
D020734	Parkinsonian Disorders

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D001480	Basal Ganglia Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.