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NCT Number: NCT06799923

Possibilities of Use MRI-Guided Laser Interstitial Thermal Therapy in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Salouël, 80480, France

Location status: Recruiting

Location contact

Claire THIRIEZ, MD

PRINCIPAL_INVESTIGATOR

David MALTETE, Pr

PRINCIPAL_INVESTIGATOR

Jean-Claude BOUFFETEAU, MD

PRINCIPAL_INVESTIGATOR

Melissa Tir, MD

SUB_INVESTIGATOR

Michel Lefranc, Pr

CONTACT

[email protected]

0322088950 ext. 33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser electrode

Procedure

A laser electrode is implanted surgically in the ventral and inteermediary nucleus of the thalamus (VIM).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michel LEFRANC, Pr

CONTACT

[email protected]

0322088950 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

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

Registry information

Official study title

Possibilities of Use Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in Treatment of Medically Intractable Tremor

Acronym: PossibiLITT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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