Possibilities of Use MRI-Guided Laser Interstitial Thermal Therapy in Medically Intractable Tremor (PossibiLITT)

January 28, 2025 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Salouel, France, 80480
        • Recruiting
        • CHRU Amiens
        • Principal Investigator:
          • Claire THIRIEZ, MD
        • Contact:
        • Sub-Investigator:
          • Melissa Tir, MD
        • Principal Investigator:
          • David MALTETE, Pr
        • Principal Investigator:
          • Jean-Claude BOUFFETEAU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parkinson's disease
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
Procedure: laser electrode
A laser electrode is implanted surgically in the ventral and inteermediary nucleus of the thalamus (VIM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative fluid balance
Time Frame: at 72 hours
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.
at 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

University Hospital, Rouen
Central Hospital Saint Quentin
University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021_843_0110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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