Vagus Nerve Stimulation Modulation of the Coeruleus-Norepinephrine Network
Vagus Nerve Stimulation Modulation of the Coeruleus-Norepinephrine Network: The implant surgery is performed under general anesthesia. The generator is implanted subcutaneously in the left upper chest or left axillary border. The electrode lead wire is attached to the left mid-cervical vagus nerve through a second incision in the left neck area. The lead wire is passed through a subcutaneous tunnel and attached to the pulse generator.
Study summary
A randomized controlled clinical study will be conducted in Xuanwu Hospital of Capital Medical University. This study initially explore the effect of selective vagus nerve(C fiber) stimulation on mild-to-moderate AD patients, in order to regulate the activity of the locus coeruleus-norepinephrine network, and to observe the improvement of cognitive function and memory function. We aim to evaluate the efficacy and safety of minimally invasive selective vagus nerve stimulation in the treatment of mild-to-moderate AD patients, to clarify the effective mechanism, and to provide an effective clinical treatment strategy.
Eligibility
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Referring to the NIA-AA clinical AD diagnostic criteria formulated by 2011 National Institute on Aging (NIA) and Alzheimer's Disease Association (ADA) groups, select mild to moderate AD patients with positive amyloid PET;
2. Male or female AD patients between the ages of 50-85;
3. Neuropsychological evaluation reaches the following standards: MMSE 16-24 points, CDR 0.5-2 points;
4. Patients who receives a stable cholinesterase inhibitor regimen continues the oral drug with the same dose for at least 8 weeks before entering the study
5. The patient has sufficient proficiency in Mandarin Chinese and is able to complete the cognitive assessment form;
6. Those who voluntarily accept the test and sign an informed consent form.
Exclusion Criteria:
1. There is a clear history of cerebrovascular stroke, and there are clear symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left on neuroimaging;
2. Those with a history of alcoholism, or drug addiction, or neurological diseases that can cause cognitive impairment, such as traumatic brain injury, epilepsy, encephalitis, normal intracranial pressure hydrocephalus;
3. Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency);
4. Suffering from cardiac conductive dysfunction (bradycardia) or sleep apnea syndrome;
5. Participating in other drug clinical trials;
6. There are contraindications to head MRI.
7. Those who are deemed unsuitable to participate the trial by the investigator.
Primary outcome measure(s)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) — 26 weeks To evaluate the improvement of the cognitive state of AD patients
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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