NCT06799923 Possibilities of Use MRI-Guided Laser Interstitial Thermal Therapy in Medically Intractable Tremor
| NCT ID | NCT06799923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Laser Interstitial Thermal Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-08-01 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06799923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Laser Interstitial Thermal Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06799923 currently recruiting?
Yes, NCT06799923 is actively recruiting participants. Contact the research team at lefranc.michel@chu-amiens.fr for enrollment information.
Where is the NCT06799923 trial being conducted?
This trial is being conducted at Salouël, France.
Who is sponsoring the NCT06799923 clinical trial?
NCT06799923 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 15 participants.