Xuanwu Hospital, Capital Medical University
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- VaD-MCI
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Clinical Global Impression Scale
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
A multicenter randomized controlled clinical study was conducted in the Xuanwu hospital of Capital Medical University to preliminarily explore the efficacy and safety of simultaneous cognitive training with transcranial magnetic stimulation in the treatment of VaD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.
Detailed Description
This project plans to recruit 164 patients with VaD-MCI. They were randomly divided into simultaneous cognitive training with active transcranial magnetic stimulation group and simultaneous cognitive training with sham transcranial magnetic stimulation group. Patients receive treatment 3-7 days a week, and the daily treatment time is 20-40 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female VaD-MCI patients between the ages of 50-85; The psychological evaluation was in accordance with MMSE score of 18-26 (including 18 and 26) and CDR score of 0.
- •The inclusion criteria based on MRI examination include: ① Multiple supratentorial subcortical lacunae (3-20 mm) with or without white matter degeneration, or moderate and severe white matter degeneration (Fazekas score ≥2) with or without lacunae; ② White matter lesions such as cortical/watershed infarction, cerebral hemorrhage, hydrocephalus or other causes (such as multiple sclerosis) were excluded; ③ There was no medial atrophy of hippocampus or temporal lobe (MTA 0); Can cooperate to complete clinical research.
Exclusion Criteria
- •Suffering from any cause of disturbance of consciousness. Severe aphasia or physical disability can not complete the neuropsychological examination 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.
Outcomes
Primary Outcomes
Clinical Global Impression Scale
Time Frame: 1-12 weeks
Evaluate the improvement of clinical symptoms
Secondary Outcomes
- resting EEG(1-12 weeks)
- head MRI(1-12 weeks)