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

NCT ID: NCT06799923

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Laser Interstitial Thermal Therapy Parkinson Disease Essential Tremor Movement Disorders MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

laser electrode

Intervention Type PROCEDURE

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

Interventions

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laser electrode

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role collaborator

Central Hospital Saint Quentin

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Amiens

Salouël, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Michel LEFRANC, Pr

Role: CONTACT

0322088950 ext. 33

Facility Contacts

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Michel Lefranc, Pr

Role: primary

0322088950 ext. 33

Other Identifiers

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PI2021_843_0110

Identifier Type: -

Identifier Source: org_study_id

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