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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: MRI; Laser Interstitial Thermal Therapy; Essential Tremor; Movement Disorders; Parkinson Disease

Treatments: Procedure: laser electrode

Study type: Interventional

Funder types: Other

Identifiers

NCT06799923

PI2021_843_0110

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Parkinson's disease

Experimental group

Description:

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

Treatment:

Procedure: laser electrode