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

NCT06799923 | Recruiting

• 1 other identifier: PI2021_843_0110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

laser interstitial thermal therapy; Parkinson Disease; Essential Tremor; Movement Disorders; MRI

Outcome Measures

Primary Outcomes (1)

• Variation of total body weight from baseline

  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.

  at 72 hours

Secondary Outcomes (1)

• cumulative fluid balance

  at 72 hours

Study Arms (1)

Parkinson's disease

EXPERIMENTAL

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

Procedure: laser electrode

Interventions

laser electrode PROCEDURE

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

Parkinson's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Rouen: collaborator
• University Hospital, Caen: collaborator
• Central Hospital Saint Quentin: collaborator

Study Sites (1)

CHRU Amiens

Salouël, 80480, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Michel LEFRANC, Pr

CONTACT

0322088950; lefranc.michel@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: January 29, 2025
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)