Directional PSA Versus STN DBS for TD-PD
ConditionParkinsons Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital
About this trial
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) using directional lead for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
Eligibility criteria
Qualifiers
diagnosis of idiopathic Parkinson's disease
tremor-dominant subtype in the off-medication condition
modified Hoehn-Yahr scale of 2 to 4 in the off-medication condition
receiving regular anti-parkinsonian drugs for more than 6 weeks
Disqualifiers
Atypical parkinsonism
History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
Presence of anatomical abnormalities in the target region
Trial design
Treatments tested in this trial
- directional Deep brain stimulation
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov