About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
laser electrode
Procedure/SurgeryA laser electrode is implanted surgically in the ventral and inteermediary nucleus of the thalamus (VIM).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
cumulative fluid balance
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire, Amiens
Lead sponsor
University Hospital, Rouen
Collaborator
University Hospital, Caen
Collaborator
Central Hospital Saint Quentin
Collaborator