Fornix and NbM as Targets of Stimulation In Alzheimer's Disease
NCT ID: NCT03352739
Last Updated: 2018-01-11
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
30 participants
INTERVENTIONAL
2017-12-01
2020-12-01
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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DBS of the fornix, power on
DBS of the fornix, power on
DBS of bilateral columns of the fornix is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on .
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
DBS of the NbM, power on
DBS of the NbM, power on
DBS of bilateral NbMs is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on .
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
DBS of the fornix, power off
DBS of the fornix, power off
DBS of bilateral columns of the fornix is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation.
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
DBS of the NbM, power off
DBS of the NbM, power off
DBS of bilateral NbMs is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation.
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
Control group
The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.
No interventions assigned to this group
Interventions
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DBS of the fornix, power on
DBS of bilateral columns of the fornix is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on .
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
DBS of the NbM, power on
DBS of bilateral NbMs is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on .
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
DBS of the fornix, power off
DBS of bilateral columns of the fornix is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation.
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
DBS of the NbM, power off
DBS of bilateral NbMs is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation.
DBS system includes:
Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
Eligibility Criteria
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Inclusion Criteria
2. 45-75 years of age;
3. At least 6 years of education;
4. AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011);
5. Clinical Dementia Rating Scale (CDR): 1.0-2.0;
6. Positive findings with amyloid PET imaging;
7. Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period.
Exclusion Criteria
2. Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4；
3. Modified Hachinski ischemic score\>4；
4. Young Mania Rating Scale\>11(Young, Biggs, Ziegler, \& Meyer, 1978);
5. Any suicidal tendencies in recent 2 years;
6. Cornell Scale for Depression and Dementia\>10;
7. Familial AD;
8. Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
9. Surgical history of the central nervous system;
10. Severe cardiovascular/pulmonary disorders.
45 Years
75 Years
ALL
No
Sponsors
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Beijing Pins Medical Co., Ltd
INDUSTRY
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital, Capital Medical University.
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Peng-Hu Wei, M.D.
Role: primary
Other Identifiers
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XuanwuH
Identifier Type: -
Identifier Source: org_study_id
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