Effects of Transcranial Ultrasound Stimulation (TUS) on Neurological and Cognitive Outcomes in Neurodegenerative Diseases (NDD-01)

Sanmai Technologies

Status: Enrolling

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

Treatments: Device: Transcranial focused ultrasound modulation administered to a region involved in disease pathology.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07207122

NeurodegenerativeDisorders-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Open label transcranial focused ultrasound neuromodulation

Experimental group

Description:

We will target a brain region involved in disease pathology.

Treatment:

Device: Transcranial focused ultrasound modulation administered to a region involved in disease pathology.