Severe Upper Limb Tremor Refractory to Medical Therapy
Conditions
Brief summary
Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually achieved using stereotactic surgical procedures. Radiosurgery of invisible targets to treat movement disorders and intractable pain are still the domain of frame-based procedures, due to the need of a solid reference system registered to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of stereotactic atlases. In this study we want to utilize a mathematical method that uses atlas-derived stereotactic coordinates to perform frameless images-guided radiosurgery of such functional targets Particularly the aim of the present study is to investigate both the efficacy and the safety of the methodology to treat upper limb and hand tremor in elderly or in patients which are not ot susceptible of surgical procedures. For these reasons a dose escalation prospective trial have been designed.
Interventions
RADIATIONRadiosurgical thalamotomy
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients affected by severe upper limb tremor refractory to medical therapy and who are candidate for a deep brain stimulation (DBS) procedure. * Age: ≥ 18 years old * Refusal of DBS procedure * Written consent
Exclusion criteria
* Pregnancy * Allergy to contrast medium * DBS procedure susceptibility, if not refused
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tremor control (improvement in FTMTRS and/or UPDRS motor) | 2 years | Tremor control (improvement in Fahn Tolosa Marin Tremor Rating Scale, FTMTRS, and/or Unified Parkinson's Disease Rating Scale, UPDRS, motor) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered). | 2 years | — |
| The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3. | 2 years | The treatment safety will be evaluated. Toxicity will be registered according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 3,NCI-CTCAE v3. |
Countries
Italy
Outcome results
None listed