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

NCT07207122 | Recruiting

• 1 other identifier: NeurodegenerativeDisorders-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 life for patients with neurodegenerative diseases.

Conditions

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

Keywords

Alzheimer's; Parkinson's; Low-intensity focused ultrasound neuromodulation; noninvasive neuromodulation; mild cognitive impairment; Parkinson's disease dementia

Outcome Measures

Primary Outcomes (6)

• Finger Tapping

  A simple motor assessment used to measure speed, rhythm, and coordination of repetitive finger movements.

  2 weeks

• 10-meter Timed Walk

  A simple gait assessment in which a person is asked to walk 10 meters at a comfortable or maximum pace while the time taken is recorded. The test provides objective measures of walking speed and mobility.

  2 weeks

• Archimedes Spiral Test

  A motor assessment in which a person is asked to draw a spiral on paper or a touchscreen. The accuracy, smoothness, and steadiness of the drawing provide a measure of tremor severity, fine motor control, and coordination.

  2 weeks

• PDQ-39

  The Parkinson's Disease Questionnaire-39 (PDQ-39) is a standardized self-report measure of health-related quality of life in people with Parkinson's disease. It includes 39 questions across eight domains-such as mobility, daily living, emotional well-being, stigma, and social support-providing a comprehensive view of how the condition impacts everyday life.

  2 weeks

• GAD-7

  The Generalized Anxiety Disorder 7-item (GAD-7) scale is a brief self-report questionnaire used to screen for and assess the severity of anxiety symptoms. It is widely applied in both clinical practice and research to monitor treatment outcomes and track changes over time.

  2 weeks

• Beck Depression Inventory

  The Beck Depression Inventory is a widely used self-report questionnaire that measures the presence and severity of depressive symptoms. It includes a series of multiple-choice items covering mood, cognitive patterns, and physical symptoms, making it useful for both clinical assessment and research.

  2 weeks

Secondary Outcomes (6)

• Finger Tapping

  1 month

• 10-meter timed walk test

  1 month

• Archimedes Spiral Test

  1 month

• PDQ-39

  1 month

• GAD-7

  1 month

Study Arms (1)

Open label transcranial focused ultrasound neuromodulation

EXPERIMENTAL

We will target a brain region involved in disease pathology.

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

Interventions

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

Using Sanmai's device to administer tFUS to regions of interest.

Open label transcranial focused ultrasound neuromodulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanmai Technologies PBC dba Sanmai: lead
• Acacia Research: collaborator
• University of New Mexico: collaborator
• BrainMind: collaborator
• The Regenesis Project: collaborator

Study Sites (1)

The Regenesis Project

Santa Monica, California, 90403, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jay Sanguinetti, PhD

  Sanmai Technologies, PBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor Kuhn, PhD, ABPP/CN

CONTACT

321-698-1832; taylor.k@sanm.ai

Jay Sanguinetti, PhD

CONTACT

650-335-8465; jay.s@sanm.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-04

Locations

US (1)