Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study
NCT ID: NCT04616521
Last Updated: 2020-12-24
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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NOT_YET_RECRUITING
NA
1000 participants
INTERVENTIONAL
2021-01-01
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Asymmetric DBS group
In this arm, a one-staged combined unilateral STN and contralateral GPi DBS will be implanted into PD patients. For postural instability and gait difficulty (PIGD)-dominant patients, the GPi in the side contralateral to the leg with longer step length will be targeted. For tremor-dominant (TD) patients, the STN in the side contralateral to the body side that mostly affected will be targeted. For PD patients of mixed type, the choice of target will depend on the judgement of a multidisciplinary team based on clinical features.
Deep brain stimulation
The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.
Interventions
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Deep brain stimulation
The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.
Eligibility Criteria
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Inclusion Criteria
* Aged more than 18 years
* Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III
* the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition
* Compliance with written informed consent
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 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
* Clinically significant medical history or that increases 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
ALL
No
Sponsors
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Huashan Hospital
OTHER
Shanghai Tongji Hospital, Tongji University School of Medicine
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
West China Hospital
OTHER
Second Affiliated Hospital of Soochow University
OTHER
Tianjin Huanhu Hospital
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Bomin Sun
Director of Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Central Contacts
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Other Identifiers
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Ruijin_ADP
Identifier Type: -
Identifier Source: org_study_id