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Sound waves aimed at the brain: can ultrasound pulses help preserve memory?

NCT ID NCT07883148

Symptom relief Sponsor: IRCCS San Raffaele Roma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Researchers are testing transcranial pulse stimulation (TPS), a non-invasive technique that delivers short ultrasound pulses to the brain, in people with mild cognitive impairment or early Alzheimer's disease. Participants receive either real TPS or a sham treatment for about 30 minutes a day, five days a week, for four weeks. The study measures changes in episodic memory and uses brain scans and EEG to track connectivity and brain structure. The goal is to learn whether TPS can support memory and brain function over the short and long term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcranial pulse stimulation, a non-invasive ultrasound brain treatment
What this could lead to
If it works, TPS could offer a non-invasive way to support memory and brain connections in people with mild cognitive impairment or early Alzheimer's disease.
What could go wrong
This is a small, early-stage study, and brain stimulation for Alzheimer's has a mixed track record. Benefits may be modest or temporary, and the sham-controlled design means some participants receive inactive treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

52 people

The number who actually took part.

Started

May 2024

Finished

Sep 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion criteria for MCI due to AD will be as follows: * Individuals aged ≥18 years; if women, in menopause since at least 2 years; * fulfilling the diagnostic criteria for MCI due to AD; * Mini-Mental State Examination (MMSE) score ≥24; * Clinical Dementia Rating (CDR) ≤0.5; * Stable presence of an informant family member; * Release of written informed consent prior to the study participation; * Capacity of full compliance with the protocol requirements. Inclusion criteria for AD will be as follows: * Individuals aged ≥18 years; if women, in menopause since at least 2 years; * Fulfilling the diagnostic criteria for AD; * Mini-Mental State Examination (MMSE) score ≥18; * Clinical Dementia Rating (CDR) =1; * At least 3 months of stable antidementia therapy (if any); * Stable presence of an informant family member; * Release of written informed consent prior to the study participation; * Capacity of full compliance with the protocol requirements. Exclusion Criteria: Exclusion criteria for both MCI due to AD and AD will be the following: * Individuals with comorbidities which may interfere with cognitive status (e.g., previous stroke, normal pressure, hydrocephalus, alcohol abuse, brain tumor or brain metastasis); * Previous medical history positive for psychiatric diseases (except for a recent onset of depression or other behavioral disturbances); * Treatments which may interfere with cognitive status; * Blood clotting disorders, epilepsy, and corticosteroid treatment in the last 6 weeks; * Any contraindication to TPS; * Non-compliance with the protocol requirements.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Mild cognitive impairment

Contacts and locations

Locations

  • IRCCS San Raffaele

    Roma, Italy, 00163, Italy

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