Laser Interstitial Thermal TherapyPossibiLITTNCT06799923
Possibilities of Use MRI-Guided Laser Interstitial Thermal Therapy in Medically Intractable Tremor
A study testing laser electrode in people with Laser Interstitial Thermal Therapy and Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Medically intractable tremors are a common difficult clinical situation. Deep brain stimulation decreases Parkinson's disease tremor and essential tremor, but not all patients are candidates from a diagnostic, medical, or social standpoint, prompting the need for alternative surgical strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laser Interstitial Thermal Therapy, Parkinson Disease, Essential Tremor
- What is being tested?
- laser electrode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2024to Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years age or older with Parkinson\'s disease or essential tremor and tremor resistant to medical therapy with a contraindication to deep brain stimulation or refusal deep brain stimulation
Who cannot join
- Contraindication to MRI
- Contraindication to general anesthesia
- Patient unable to give their free and informed consent because of cognitive or psychiatric disorders
- Brain anatomical abnormalities not allowing intervention
- Adults protected (guardianship, curators) or deprived of liberty.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Salouël, 80480
Michel Lefranc, Pr, 0322088950 ext. 33, lefranc.michel@chu-amiens.fr
Melissa Tir, MD
About this study
Official title: Possibilities of Use Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in Treatment of Medically Intractable Tremor
Medically intractable tremors are a common difficult clinical situation. Deep brain stimulation decreases Parkinson's disease tremor and essential tremor, but not all patients are candidates from a diagnostic, medical, or social standpoint, prompting the need for alternative surgical strategies. Less invasive lesional brain surgery (thalamotomy) procedures by radio-surgery or MRI-guided focused ultrasound have emerged and have proven to be effective in these third-line indications. Recently, a new technology has emerged allowing the performance of minimally invasive lesion surgeries by MRI-Guided Laser Interstitial Thermal Therapy (MRIg-LITT). MRIg-LITT has been shown to be effective and safe in management of epilepsies and brain tumors. However, no study has evaluated MRIg-LITT for performing thalamotomy in medically intractable tremor.In a pilot study, the investigators propose to evaluate the effect and safety of unilateral thalamotomy by MRIg-LITT in the management of medically intractable tremor of parkinsonian or essential origin.
- Conditions
- Laser Interstitial Thermal Therapy, Parkinson Disease, Essential Tremor, Movement Disorders, MRI
- Being tested
- laser electrode
- Keywords
- laser interstitial thermal therapy, Parkinson Disease, Essential Tremor, Movement Disorders, MRI
- Medical subject headings
- Parkinson Disease, Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser electrodeProcedure or surgery
A laser electrode is implanted surgically in the ventral and inteermediary nucleus of the thalamus (VIM).
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Experimental | Patients 18 years age or older with Parkinson's disease or essential tremor and tremor resistant to medical therapy with a contraindication to deep brain stimulation or refusal deep brain stimulation Receives: Procedure: laser electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of total body weight from baseline
To assess the impact of UF prescription guided by the ECW/TBWat ratio on weight loss, a comparison of TBW (∆TBW) between the two groups will be conducted. The ∆TBW is the difference between the initial TBW at H0 and the TBW at H72.
Measured: at 72 hours
Secondary outcomes (1)
cumulative fluid balance
Cumulative fluid balance is the difference between fluids administered (intravenous fluids, blood products, enteral nutrition, replacement fluid from RRT) and fluid loss (weight loss from RRT, urine output, blood loss, enteral loss, and losses through drains). It is calculated using the cumulative net UF from RRT and the hospital software (DianeRéa, Bowmedical, version 4.8.11.22887) over the period from H0 to H72.
Measured: at 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Aug 2024
- Primary completionSep 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser Interstitial Thermal TherapyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Caen, Central Hospital Saint Quentin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799923
- Sponsor's protocol ID
- PI2021_843_0110
- Acronym
- PossibiLITT
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possibilities of Use Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in Treatment of Medically Intractable Tremor
- ClinicalTrials.gov ID
- NCT06799923
- Acronym / sponsor ID
- PossibiLITT / PI2021_843_0110
- Conditions
- Laser Interstitial Thermal Therapy, Parkinson Disease, Essential Tremor, Movement Disorders, MRI
- Keywords
- laser interstitial thermal therapy, Parkinson Disease, Essential Tremor, Movement Disorders, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Caen, Central Hospital Saint Quentin
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
Medically intractable tremors are a common difficult clinical situation. Deep brain stimulation decreases Parkinson's disease tremor and essential tremor, but not all patients are candidates from a diagnostic, medical, or social standpoint, prompting the need for alternative surgical strategies. Less invasive lesional brain surgery (thalamotomy) procedures by radio-surgery or MRI-guided focused ultrasound have emerged and have proven to be effective in these third-line indications. Recently, a new technology has emerged allowing the performance of minimally invasive lesion surgeries by MRI-Guided Laser Interstitial Thermal Therapy (MRIg-LITT). MRIg-LITT has been shown to be effective and safe in management of epilepsies and brain tumors. However, no study has evaluated MRIg-LITT for performing thalamotomy in medically intractable tremor.In a pilot study, the investigators propose to evaluate the effect and safety of unilateral thalamotomy by MRIg-LITT in the management of medically intractable tremor of parkinsonian or essential origin.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | Experimental | Procedure: laser electrodePatients 18 years age or older with Parkinson's disease or essential tremor and tremor resistant to medical therapy with a contraindication to deep brain stimulation or refusal deep brain stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years age or older with Parkinson\'s disease or essential tremor and tremor resistant to medical therapy with a contraindication to deep brain stimulation or refusal deep brain stimulation
Key exclusion criteria (5 listed)
- Contraindication to MRI
- Contraindication to general anesthesia
- Patient unable to give their free and informed consent because of cognitive or psychiatric disorders
- Brain anatomical abnormalities not allowing intervention
- Adults protected (guardianship, curators) or deprived of liberty.
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 |
|---|---|---|
| laser electrodeA laser electrode is implanted surgically in the ventral and inteermediary nucleus of the thalamus (VIM). | Procedure or surgery | Parkinson's disease |
Primary outcome
Variation of total body weight from baseline
Time frame: at 72 hours
To assess the impact of UF prescription guided by the ECW/TBWat ratio on weight loss, a comparison of TBW (∆TBW) between the two groups will be conducted. The ∆TBW is the difference between the initial TBW at H0 and the TBW at H72.
1 secondary outcome
cumulative fluid balance
Time frame: at 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser electrode in people with Laser Interstitial Thermal Therapy and Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jan 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel LEFRANC, Pr (0322088950 ext. 33, lefranc.michel@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of total body weight from baseline (time frame: at 72 hours). 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 29 Jan 2025.