Status:
RECRUITING
Effects of Transcranial Ultrasound Stimulation (TUS) on Neurological and Cognitive Outcomes in Neurodegenerative Diseases
Lead Sponsor:
Sanmai Technologies PBC dba Sanmai
Collaborating Sponsors:
Acacia Research
University of New Mexico
Conditions:
Parkinson Disease
Parkinson's Disease (PD)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07207122
Start Date
October 8 2025
End Date
August 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
The Regenesis Project
Santa Monica, California, United States, 90403