RecruitingNot ApplicableNCT07207122

Effects of Transcranial Ultrasound Stimulation (TUS) on Neurological and Cognitive Outcomes in Neurodegenerative Diseases

Effects of Transcranial Ultrasound Stimulation (TUS) on Neurological and Cognitive Outcomes in Neurodegenerative Diseases.

Sponsor

Sanmai Technologies PBC dba Sanmai

Enrollment

20 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Alzheimer's Disease (AD)Mild Cognitive Impairment Parkinson's Disease (PD)Parkinson's Disease Dementia (PDD)Parkinson's Disease Dementia Alzheimer's

Summary

The purpose of this study is to evaluate the safety and efficacy of transcranial focused ultrasound neuromodulation in improving neural function, cognitive and behavioral performance, and quality of life for patients with neurodegenerative diseases.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Age 18-80 years
Ability to read and understand English
Clinical diagnosis of Alzheimer's, Parkinson's, Parkinson's dementia, mild cognitive impairment
Normal or corrected to normal vision and hearing
Must be medically stable as determined by investigators

Exclusion Criteria16

History of significant neurological disorders unrelated to the target disease
Implanted medical devices or metal implants incompatible with TUS or MRI
Uncontrolled heart or cardiac conditions or implants: severe arrhythmia, myocardial infarction, arterial angina
Psychiatric Conditions: individuals diagnosed with obsessive-compulsive disorder, psychosis, and/or bipolar disorder. Final eligibility will be determined after a thorough evaluation by the study clinicians.
Brain surgery, history of significant brain injury, seizures, or drug use deemed likely to interfere with participant safety or the experiment
Medications or drugs: A comprehensive review of current medications will be conducted by the study team. Medications known to significantly increase the risk of seizures or interact with study interventions will be carefully evaluated for safety. Final decisions on eligibility regarding medication use will be made by the study clinicians and/or PIs.
No other recreational drug use for at least 1 month prior to first treatment session
History of epilepsy: the prospective participant has had multiple seizures. If they have had one febrile seizure, provoked seizure, or acute symptomatic seizure, they may be included.
Current pregnancy
History of migraines (more than 4 days per month in the last 3 months)
Initiation of new neuromodulation or pharmacological treatment with last 6 weeks
Current cancer, or less than 5 years of remission from cancer
Weight over 350 lbs
Uncorrected hearing or visual impairment
Ingests more than 150mg of nicotine a day
Drug or alcohol addiction