Using MRI-guided laser therapy for treating severe tremors
Possibilities of Use Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in Treatment of Medically Intractable Tremor
This study is testing a new laser treatment guided by MRI to see if it can help people with severe tremors from Parkinson's disease or essential tremor feel better without needing more invasive surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Salouël) |
| Trial ID | NCT06799923 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of MRI-guided Laser Interstitial Thermal Therapy (MRIg-LITT) for performing thalamotomy in patients with medically intractable tremors, specifically those with Parkinson's disease or essential tremor. The approach aims to provide a less invasive alternative to traditional deep brain stimulation, which is not suitable for all patients. By utilizing MRI technology, the study seeks to precisely target and treat areas of the brain responsible for tremors. The pilot study will assess the outcomes of this innovative technique in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Parkinson's disease or essential tremor that is resistant to medical therapy and who cannot undergo deep brain stimulation.
Not a fit: Patients with contraindications to MRI, general anesthesia, or those unable to provide informed consent due to cognitive or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new treatment option for patients with severe tremors who are not candidates for deep brain stimulation.
How similar studies have performed: While MRIg-LITT has shown effectiveness in managing other conditions like epilepsy and brain tumors, this specific application for tremors is novel and has not been previously evaluated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salouël
- CHRU Amiens — Salouël, France (Recruiting)
Study contacts
- Study coordinator: Michel LEFRANC, Pr
- Email: lefranc.michel@chu-amiens.fr
- Phone: 0322088950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.