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Nerve pain device study abandoned after only 2 patients

NCT ID NCT04649554

Symptom relief Sponsor: InSightec 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called Exablate, which uses focused sound waves to treat areas of the brain linked to pain. The goal was to see if it could reduce pain and improve quality of life in people with chronic nerve pain. Only 2 people enrolled before the study was stopped, so no meaningful results were obtained.

What this could mean

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

Active substance
Exablate (MRgFUS) device
What this could lead to
If it had worked, this could point toward a non-invasive treatment for chronic nerve pain.
What could go wrong
The study was terminated early with only 2 participants, so no reliable conclusions can be drawn. The approach may not be effective or safe for broader use.

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

2 people

The number who actually took part.

Started

Oct 2020

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

30 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: * Men and women age 30 years or older * Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG) * Patient has a score of 6 or higher on the Numeric Rating Scale (NRS) * Evidence that the subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes * Evidence that the subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation Exclusion Criteria: * Subject diagnosed with a nociceptive chronic pain syndrome * Subject does not agree to participate or is unlikely to participate for the entirety of the study * Subject is currently participating in another clinical investigation with an active treatment arm

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Conditions

The condition(s) this trial relates to.

neuralgia trigeminal neuralgia

As listed by the trial registrant

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

Neuropathic pain

Contacts and locations

Locations

  • Fondazione IRCCS Neurologico Carlo Besta

    Milan, 20133, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.