Essential Tremor, Laser Interstitial Thermal Therapy, Movement Disorders, MRI, Parkinson Disease
Conditions
Keywords
laser interstitial thermal therapy, Parkinson Disease, Essential Tremor, Movement Disorders, MRI
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.
Interventions
PROCEDURElaser electrode
A laser electrode is implanted surgically in the ventral and inteermediary nucleus of the thalamus (VIM).
Sponsors
University Hospital, Rouen
University Hospital, Caen
Central Hospital Saint Quentin
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactMichel LEFRANC, Pr
Outcome results
None listed