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

Sponsor
Centre Hospitalier Universitaire, Amiens
Study ID
NCT06799923
Status
Recruiting
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Conditions

  • Essential Tremor
  • Laser Interstitial Thermal Therapy
  • MRI
  • Movement Disorders
  • Parkinson Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 29, 2025
Start date
Aug 1, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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

Primary Outcome Measure

Variation of total body weight from baseline [ Time Frame: at 72 hours ]

Central Contacts

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