TremorOptiRSNCT06698029
Optimizing VIM Targeting for Radiosurgery in Severe Tremor
A study testing VIM Targeting in people with Tremor and Laser Therapy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Essential tremor is a common neurological disease, the most severe form of which combines postural and intention tremor, with significant physical, psychological and social repercussions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tremor, Laser Therapy
- What is being tested?
- VIM Targeting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced, disabling, drug-resistant essential tremor
- Patient selected as part of the multidisciplinary concertation meeting on abnormal movements
- Patient aged 18 to 85
- Brain MRI showing no anatomical abnormality contraindicating radiosurgical procedure
- MATTIS ≥ 130
- Subject affiliated to or benefiting from a social security scheme
- Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
Who cannot join
- Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Jean REGIS, 0491387059 ext. 33, jean.regis@ap-hm.fr
About this study
Official title: Optimisation du Ciblage du VIM Pour la Radiochirurgie Dans le Tremblement sévère
Essential tremor is a common neurological disease, the most severe form of which combines postural and intention tremor, with significant physical, psychological and social repercussions. It is in these most severe forms that surgical lesioning of the ventro-intermediate nucleus of the thalamus (VIM) has been proposed. The VIM and its region of interest are almost impossible to identify directly on imaging (especially MRI), as it is part of the thalamus, which has the same intensity. To identify it, teams use average coordinates from stereotactic atlases (imprecise due to the high inter-individual variability of brain anatomy) or retrospective series of implanted patients. The hypothesis of the present trial is that the VIM-RS-LAT-1.0 algorithm developed by RebrAIn for radiosurgery will enable targeting that is at least as effective as conventional targeting. This is a single-center, controlled study, the primary endpoint of which will be assessed at one year, in a blinded, phase 3, comparative, non-inferiority, randomized study in two parallel groups of patients with severe tremor undergoing radiosurgery. In the control group, VIM will be targeted conventionally, and in the experimental group, VIM will be targeted by the RebrAIn algorithm (VIM-RS-LAT-1.0 model) of radiosurgery.
- Conditions
- Tremor, Laser Therapy
- Being tested
- VIM Targeting
- Medical subject headings
- Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIM TargetingOther
Targeting with the use of VIMRS-LAT-1.0
| Study group | Role | What they receive |
|---|---|---|
| VIM radiosurgery with RebrAIn targeting technique | Experimental | VIM radiosurgery with RebrAIn targeting technique (model VIM-RS-LAT-1.0) Receives: Other: VIM Targeting |
| VIM radiosurgery standard targeting technique | No intervention | VIM radiosurgery standard targeting technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage improvement in tremor in the treated upper limb
Assessed on a composite tremor assessment criterion that strictly replicates the endpoint of the prospective study. The percentage will be considered as a continuous variable, between 0 and 100%, and will be assessed blindly by a single practitioner.
Measured: between inclusion and one year post-operatively (after radiosurgery)
Secondary outcomes (6)
The percentage of improvement in quality of life
QUEST scale
Measured: Between inclusion and one year post-operatively (after radiosurgery)
Assessment of % change in postural balance
SARA scale
Measured: Between inclusion and one year post-operatively (after radiosurgery)
Assessment of tolerability
Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination
Measured: At 12 months
Assessment of cognitive performance
Score of Mattis Dementia Rating Scale and the Verbal Fluency Test
Measured: At one year postradiosurgery
Assess lesion location in relation to targeting
MRI
Measured: 12 months after radiosurgery
Medico-economic evaluation of automatic targeting compared with conventional targeting
QALY and EQ5D-5L scores
Measured: 12 months after radiosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TremorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698029
- Sponsor's protocol ID
- RCAPHM23_0448
- Acronym
- OptiRS
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation du Ciblage du VIM Pour la Radiochirurgie Dans le Tremblement sévère
- ClinicalTrials.gov ID
- NCT06698029
- Acronym / sponsor ID
- OptiRS / RCAPHM23_0448
- Conditions
- Tremor, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Nov 2024 (actual)
- 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 is a common neurological disease, the most severe form of which combines postural and intention tremor, with significant physical, psychological and social repercussions. It is in these most severe forms that surgical lesioning of the ventro-intermediate nucleus of the thalamus (VIM) has been proposed. The VIM and its region of interest are almost impossible to identify directly on imaging (especially MRI), as it is part of the thalamus, which has the same intensity. To identify it, teams use average coordinates from stereotactic atlases (imprecise due to the high inter-individual variability of brain anatomy) or retrospective series of implanted patients. The hypothesis of the present trial is that the VIM-RS-LAT-1.0 algorithm developed by RebrAIn for radiosurgery will enable targeting that is at least as effective as conventional targeting. This is a single-center, controlled study, the primary endpoint of which will be assessed at one year, in a blinded, phase 3, comparative, non-inferiority, randomized study in two parallel groups of patients with severe tremor undergoing radiosurgery. In the control group, VIM will be targeted conventionally, and in the experimental group, VIM will be targeted by the RebrAIn algorithm (VIM-RS-LAT-1.0 model) of radiosurgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIM radiosurgery with RebrAIn targeting technique | Experimental | Other: VIM TargetingVIM radiosurgery with RebrAIn targeting technique (model VIM-RS-LAT-1.0) |
| VIM radiosurgery standard targeting technique | No intervention | –VIM radiosurgery standard targeting technique |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced, disabling, drug-resistant essential tremor
- Patient selected as part of the multidisciplinary concertation meeting on abnormal movements
- Patient aged 18 to 85
- Brain MRI showing no anatomical abnormality contraindicating radiosurgical procedure
- MATTIS ≥ 130
Key exclusion criteria (2 listed)
- Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)
- Pregnant or breast-feeding women
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 |
|---|---|---|
| VIM TargetingTargeting with the use of VIMRS-LAT-1.0 | Other | VIM radiosurgery with RebrAIn targeting technique |
Primary outcome
Percentage improvement in tremor in the treated upper limb
Time frame: between inclusion and one year post-operatively (after radiosurgery)
Assessed on a composite tremor assessment criterion that strictly replicates the endpoint of the prospective study. The percentage will be considered as a continuous variable, between 0 and 100%, and will be assessed blindly by a single practitioner.
6 secondary outcomes
The percentage of improvement in quality of life
Time frame: Between inclusion and one year post-operatively (after radiosurgery)
Assessment of % change in postural balance
Time frame: Between inclusion and one year post-operatively (after radiosurgery)
Assessment of tolerability
Time frame: At 12 months
Assessment of cognitive performance
Time frame: At one year postradiosurgery
Assess lesion location in relation to targeting
Time frame: 12 months after radiosurgery
Medico-economic evaluation of automatic targeting compared with conventional targeting
Time frame: 12 months after radiosurgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIM Targeting in people with Tremor and Laser Therapy, 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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 20 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean REGIS (0491387059 ext. 33, jean.regis@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage improvement in tremor in the treated upper limb (time frame: between inclusion and one year post-operatively (after radiosurgery)). 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 20 Nov 2024.