Clinical trial NCT06470113: Clinical Multicenter Randomized Controlled Study of Simultaneous Cognitive Training With Transcranial Magnetic Stimulation in the Treatment of VaD-MCI Patients
Official title: Xuanwu Hospital, Capital Medical University
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: VaD-MCI
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 164
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned to the active stimulation group and sham stimulation group.
Primary purpose: TREATMENT

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.

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 0.5.

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.

Primary outcomes:
measure: Clinical Global Impression Scale
timeFrame: 1-12 weeks
Secondary outcomes:
measure: resting EEG
timeFrame: 1-12 weeks
measure: head MRI
timeFrame: 1-12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University.
state: Beijing
Study officials:
References: