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

Not Applicable

Recruiting

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

• Registration Number: NCT06799923
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-09
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variation of total body weight from baseline	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 Outcome Measures

Name	Time	Method
cumulative fluid balance	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.

Trial Locations

Locations (1)

CHRU Amiens; 🇫🇷 Salouel, France