Deep Brain Stimulation for Cervical Dystonia
Dystonia, Generalized Primary Dystonia
About this trial
This is an interventional treatment trial for Dystonia focused on measuring Surgery, Treatment, Physiology, Pediatric, Neurosurgery, Generalized Primary Dystonia
Eligibility Criteria
INCLUSION CRITERIA: To be eligible for entry into the study, candidates must meet all the following criteria: Patients greater than 7 years of age with generalized primary dystonia. Patients who are refractory to medical treatment (including levodopa, anticholinergics, benzodiazepines, Baclofen) who are considered surgical candidates. Patients will be determined to have medical refractory dystonia after having been treated by at least two medications of two different groups at the maximum recommended dose for a duration of at least two months. In case of treatment by intrathecal Baclofen delivered by a pump, a change to oral Baclofen must be performed, so that the pump can be taken out. Patients must have a minimum BFM score of 20 on optimal medical therapy. Adults must be mentally competent to consent for entrance into the protocol at the time of admission. Patients must have a signed DPA for research purposes. EXCLUSION CRITERIA: Candidates will be excluded if: The patient has had previous lesioning surgery including radiofrequency lesioning of deep nuclei (thalamus, pallidum, STN). The patient currently has a functioning and effective stimulator in deep brain nuclei (thalamus, pallidum, STN). The patient is not able to tolerate surgery, as determined by the preoperative evaluation. The patient has a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less than 150,000 platelets/mm(3)). The patient has an acute or untreated infection (viral, bacterial or fungal). The patient has a contraindication to MR-imaging such as previous surgery that involved placement of metal objects that could cause tissue damage or produce image artifacts. The patient has another chronic neurologic disorder. The patient is pregnant at the time of surgery. The patient has epilepsy. The patient does not have access to proper follow-up care at home and may not be eligible for the study.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)