Xuanwu Hospital, Capital Medical University.
Beijing, 100053, China
NCT Number: NCT05499429
A randomized controlled clinical study was conducted in the xuanwu hospital Single Center of Capital Medical University to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with Lewy bodies in the early stage, 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, 100053, China
This project plans to recruit 20 patients with mild Lewy body dementia.They were randomly divided into transcranial focused low-intensity ultrasound active stimulation group and sham stimulation group. Patients receive treatment three days a week, and the daily treatment time is 20-30 minutes.The duration of treatment is 4-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination of glucose metabolism 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 of glucose metabolism 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
Exclusion criteria
Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.
Other names: tFUS
Time frame: 12 weeks
Evaluate the improvement of clinical symptoms.
Time frame: 12 weeks
EEG power in alpha band
Time frame: 12 weeks
Changes of brain function by fMRI
Contact information is provided by the study sponsor or research team.
Xuanwu Hospital, Beijing
Other
Clinical Single-center Randomized Controlled Trial of Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia
Acronym: tFUS in DLB
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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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