PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
NCT ID: NCT02254395
Last Updated: 2016-10-14
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
EARLY_PHASE1
8 participants
INTERVENTIONAL
2016-12-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Deep Brain Stimulation
Stimulation is on.
Deep Brain Stimulation
Placebo
Sham Stimulation: Stimulation is off.
Deep Brain Stimulation
Interventions
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Deep Brain Stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body Mass Index \[BMI\] \>40 kg/m2.
Exclusion Criteria
2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
3. Participate in other clinical trial;
4. Has a life expectancy of \< 1 year.
5. The investigator and/or enrollment review committee, would preclude participation in the study.
18 Years
65 Years
ALL
Yes
Sponsors
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Beijing Tiantan Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Li Luming, PhD
Role: STUDY_CHAIR
Tsinghua University
Central Contacts
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Other Identifiers
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PINS-010
Identifier Type: -
Identifier Source: org_study_id
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