Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-09-01
2024-12-31
Brief Summary
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Detailed Description
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After being informed about the study and potential risks, enrolled patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio using a minimization randomization method in a double-blinded manner, and later undergo bilateral DBS surgery. One group of patients will receive stimulation of left GPi and right STN, while the other will receive STN stimulation bilaterally. The follow-up period will be one year, with corresponding clinical assessments completed at six months and one year postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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L-GPi/R-STN
Participants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year.
Deep brain stimulation
active DBS with optimal stimulating parameters
Bi-STN
Participants randomized in this arm will receive bilateral STN stimulation for 1 year.
Deep brain stimulation
active DBS with optimal stimulating parameters
Interventions
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Deep brain stimulation
active DBS with optimal stimulating parameters
Eligibility Criteria
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Inclusion Criteria
* postural instability/gait difficulty (PIGD) phenotypes in the on-medication condition
Exclusion Criteria
* History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with 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
* Clinically significant medical history that would increase pre-/post-operative complications
* Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Principal Investigators
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Dianyou Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Asym Stim-PIGD
Identifier Type: -
Identifier Source: org_study_id
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