NCT05499429 · NOT YET RECRUITING
Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia
This trial tests whether a non-invasive device that sends gentle focused ultrasound waves through the skull can help people with early-stage Lewy body dementia. Researchers are looking at changes in thinking and safety. It is a device study with no phase label, so it is an early look, not proof that it works.
You may qualify if
- Male or female DLB patients between the ages of 50-85;
- The psychological evaluation was in accordance with MMSE score of 18-24 (including 18 and 24) and CDR score of 0.5.
- Can cooperate to complete clinical research.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-08-12