Xuanwu Hospital, Capital Medical University.
Beijing, Beijing Municipality, 100053, China
NCT Number: NCT06470074
A multicenter randomized controlled clinical study was conducted in the Xuanwu hospital of Capital Medical University to preliminarily explore the efficacy and safety of transcranial electrical stimulation in the treatment of AD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.
Trial opening soon.
Get Notified50 year–85 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100053, China
This project plans to recruit 124 patients with AD-MCI. They were randomly divided into transcranial electrical active stimulation group and sham stimulation group. Patients receive treatment 3-7 days a week, and the daily treatment time is 20-60 minutes. The duration of treatment is 1-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination were completed. Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination at the follow-up 6 months after the treatment. Fill in the treatment side effect scale and adverse event form. Keep the original oral drug dosage unchanged during the treatment process.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Male or female AD-MCI patients between the ages of 50-85; The psychological evaluation was in accordance with MMSE score of 18-30 (including 18 and 30) and CDR score of 0.5.
Can cooperate to complete clinical research.
Exclusion criteria
There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging.
Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.
Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).
Have a history of using antipsychotics for more than five years before diagnosis.
There are contraindications for head MRI examination.
Transcranial electrical stimulation can modulate the brain functional network through weak transcranial current
Time frame: 1-12 weeks
Evaluate the improvement of clinical symptoms
Time frame: 1-12 weeks
EEG power in multiple band
Time frame: 1-12 weeks
Changes of brain function by fMRI
Contact information is provided by the study sponsor or research team.
Xuanwu Hospital, Beijing
Other
Xuanwu Hospital, Capital Medical University
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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