Patients With Parkinson's DiseaseVIMBILNCT02827955
Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor
A study testing Gamma Knife® radiosurgery bilateral in people with Patients With Parkinson's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Patients With Parkinson's Disease
- What is being tested?
- Gamma Knife® radiosurgery bilateral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2014to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Patients With Parkinson's Disease
- Being tested
- Gamma Knife® radiosurgery bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Knife® radiosurgery bilateralDevice
| Study group | Role | What they receive |
|---|---|---|
| bilateral thalamotomy radiosurgery | Experimental | Gamma Knife radiosurgery bilateral Receives: Device: Gamma Knife® radiosurgery bilateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start3 Jun 2014
- Primary completion16 Apr 2021
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean REGIS, PUPH, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827955
- Sponsor's protocol ID
- 2013-38
- Other IDs
- 2013-A01289-36, 2013-38
- Acronym
- VIMBIL
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2016
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor
- ClinicalTrials.gov ID
- NCT02827955
- Acronym / sponsor ID
- VIMBIL / 2013-38
- Conditions
- Patients With Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bilateral thalamotomy radiosurgery | Experimental | Device: Gamma Knife® radiosurgery bilateralGamma Knife radiosurgery bilateral |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
- simultaneous participation in another clinical trial or exclusion period of a previous clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma Knife® radiosurgery bilateral | Device | bilateral thalamotomy radiosurgery |
Primary outcome
evaluation of cognitive tolerance
Time frame: 36 months
Define therapeutic technique "acceptable" in cognitive tolerance level by the Mini Mental State scale (MMS), 10% of subjects decrease their MMS over 2 points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean REGIS, PUPH principal investigator
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Knife® radiosurgery bilateral in people with Patients With Parkinson's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of cognitive tolerance (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.