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Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor (VIMBIL)

Primary Purpose

Patients With Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Gamma Knife® radiosurgery bilateral

About this trial

This is an interventional treatment trial for Patients With Parkinson's Disease

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with essential tremor defined criteria Consensus statement of the movement Disorder Society on Classical Essential Tremor (1998), with trembling of the upper limbs causing functional impairment justifying surgical therapy.
Man or woman aged 20 to 85 years.
Patient having an absolute contraindication against or on Deep Brain Stimulation (DBS) of the VIM.
Patient who received a first effective unilateral thalamotomy on tremor with a satisfactory clinical outcome (no cognitive impairment, lack of postural disorder Musculoskeletal severe lack of dysarthria). The first effective thalamotomy will be characterized by an improved score of tremor ≥ 45% and improved functional gene ≥ 50%.
Patient who received a first unilateral thalamotomy with satisfactory radiological evolution. Unsatisfactory radiological evolution will be characterized by a contrast uptake> 350 mm3 one year with edema on T2 and Flair sequences extended beyond the internal capsule.
Patient requiring contralateral treatment because of the severity of the tremor and functional impairment.
Patient affiliated to a social protection scheme.
Patient who understood and signed the informed consent form (signature of a third person possible when the patient is unable to read and / or write but in a state to give consent).

Exclusion Criteria:

Patient with against-indication for performing a brain MRI (pacemaker, intracranial metallic objects etc.)
Patient with an against-indication to radiosurgical treatment (prior treatment with cerebral radiotherapy)
Pregnant or lactating women
Women of childbearing potential unless
1. surgical sterilization
2. use of effective contraception (intrauterine device or method more hormonal barrier method), and requiring to present a test pregnancy by assaying the negative serum with chorionic gonadotrope hormon (CGH) when selecting and accept to remain under the current form of contraception for the duration of the study (in women past menopause should be amenorrheic for at least 12 months to be considered as no longer able to bear a child).
simultaneous participation in another clinical trial or exclusion period of a previous clinical trial.
vulnerable persons: minors, protected adults (guardianship) and Major unable to consent.

Sites / Locations

Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bilateral thalamotomy radiosurgery

Arm Description

Gamma Knife radiosurgery bilateral

Outcomes

Primary Outcome Measures

evaluation of cognitive tolerance

Define therapeutic technique "acceptable" in cognitive tolerance level by the Mini Mental State scale (MMS), 10% of subjects decrease their MMS over 2 points.

Secondary Outcome Measures

Full Information

NCT ID

NCT02827955

First Posted

July 6, 2016

Last Updated

April 12, 2023

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT02827955

Brief Title

Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor

Acronym

VIMBIL

Official Title

Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 3, 2014 (Actual)

Primary Completion Date

April 16, 2021 (Actual)

Study Completion Date

April 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Essential tremor (ET) is the most frequent movement disorder. Its prevalence is about 1/200 implying that at least 300 000 peoples are concerned in France. Its frequency increase with age (14% of patients 65 yo). The diagnostic criteria are postural and kinetic tremor that can be associated with head/voice tremor. ET induces a social impairment but also difficulties to perform any task requiring dexterity. With time, tremor can be so severe that every activity of daily living is impaired with loss of autonomy. Treatment such as betablockers, primidone or antiepileptics might have some efficacy at the beginning. But as the severity of the tremor increases, there is lack of efficacy. Deep Brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus can be proposed. However, in case of medical or surgical contra-indication, Gamma Knife (GK) radiosurgery thalamotomy can be an alternative option. Patients will be included with a minimum of 12 months after having the first thalamotomy (Gamma Knife 1) (done on the most annoying side) subject to no significant deterioration in cognitive assessment, voice assessment and balance and postural assessment or neuroradiological abnormality. Patients will be assessed with Magnetic resonance imaging (MRI) cerebral, clinical assessment (tremor rating scale) impairment of activity of daily living, neuropsychological evaluation, voice assessment and balance and postural assessment. The second thalamotomy (Gamma Knife 2) will be proposed and a monitoring at M6 and M12 will be done. This study will demonstrate the feasibility and tolerance of bilateral GK radiosurgery thalamotomy in ET patients with severe impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bilateral thalamotomy radiosurgery

Arm Type

Experimental

Arm Description

Gamma Knife radiosurgery bilateral

Intervention Type

Device

Intervention Name(s)

Gamma Knife® radiosurgery bilateral

Primary Outcome Measure Information:

Title

evaluation of cognitive tolerance

Description

Define therapeutic technique "acceptable" in cognitive tolerance level by the Mini Mental State scale (MMS), 10% of subjects decrease their MMS over 2 points.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with essential tremor defined criteria Consensus statement of the movement Disorder Society on Classical Essential Tremor (1998), with trembling of the upper limbs causing functional impairment justifying surgical therapy. Man or woman aged 20 to 85 years. Patient having an absolute contraindication against or on Deep Brain Stimulation (DBS) of the VIM. Patient who received a first effective unilateral thalamotomy on tremor with a satisfactory clinical outcome (no cognitive impairment, lack of postural disorder Musculoskeletal severe lack of dysarthria). The first effective thalamotomy will be characterized by an improved score of tremor ≥ 45% and improved functional gene ≥ 50%. Patient who received a first unilateral thalamotomy with satisfactory radiological evolution. Unsatisfactory radiological evolution will be characterized by a contrast uptake> 350 mm3 one year with edema on T2 and Flair sequences extended beyond the internal capsule. Patient requiring contralateral treatment because of the severity of the tremor and functional impairment. Patient affiliated to a social protection scheme. Patient who understood and signed the informed consent form (signature of a third person possible when the patient is unable to read and / or write but in a state to give consent). Exclusion Criteria: Patient with against-indication for performing a brain MRI (pacemaker, intracranial metallic objects etc.) Patient with an against-indication to radiosurgical treatment (prior treatment with cerebral radiotherapy) Pregnant or lactating women Women of childbearing potential unless surgical sterilization use of effective contraception (intrauterine device or method more hormonal barrier method), and requiring to present a test pregnancy by assaying the negative serum with chorionic gonadotrope hormon (CGH) when selecting and accept to remain under the current form of contraception for the duration of the study (in women past menopause should be amenorrheic for at least 12 months to be considered as no longer able to bear a child). simultaneous participation in another clinical trial or exclusion period of a previous clinical trial. vulnerable persons: minors, protected adults (guardianship) and Major unable to consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean REGIS, PUPH

Organizational Affiliation

Assistance Publique Hôpitaux de Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assistance Publique Hôpitaux de Marseille

City

Marseille

ZIP/Postal Code

13354

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor

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