An interventional study of Transcranial electrical stimulation in AD-MCI, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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.
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.
Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Patients were assigned into active stimulus group according to random number table
Device: Transcranial electrical stimulation
Patients were assigned into sham stimulus control group according to random number table
Device: Transcranial electrical stimulation
Transcranial electrical stimulation can modulate the brain functional network through weak transcranial current
Clinical Global Impression Scale
Evaluate the improvement of clinical symptoms
Time frame: 1-12 weeks
resting EEG
EEG power in multiple band
Time frame: 1-12 weeks
head MRI
Changes of brain function by fMRI
Time frame: 1-12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing