Essential Tremor, Movement Disorders, Neuropathic Pain, Parkinson's Disease
Conditions
Keywords
tremor, Parkinson's, movement, neuropathic, pain
Brief summary
A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.
Detailed description
A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.
Interventions
None listed
Sponsors
InSightec
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Meets labeling indication for use per information for prescribers * Target is accessible by Focused Ultrasound per treatment planning parameters
Exclusion criteria
* Do not agree to participate or who are unlikely to participate over an extended period of time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Rating Scale for Tremor | 5 year | CRST |
Countries
Canada, Israel, Taiwan, United States
Outcome results
None listed