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3-D brain mapping could sharpen ultrasound treatment for hand tremors

NCT ID NCT06331052

Disease control Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tests whether using 3-D tractography—a detailed brain imaging method—can make focused ultrasound ablation safer and more effective for people with essential tremor. Twenty-four adults with moderate to severe tremor that hasn't responded to medication will receive the procedure. Researchers will track side effects and tremor improvement over three months to see if this advanced imaging helps target the right brain area more precisely.

What this could mean

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

Active substance
MR-guided focused ultrasound ablation
What this could lead to
If successful, this could offer a more precise, non-invasive treatment option for essential tremor, potentially reducing side effects and improving tremor control.
What could go wrong
This is an early feasibility study with only 24 participants, so results may not apply to everyone. The procedure carries risks like temporary balance or speech issues, and long-term benefits are not yet known.

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

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

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

22 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: * Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians * Symptoms refractory to at least two medications * Stable essential tremor medication regimen for at least 4 weeks prior to screening * Willing and able to participate in all follow-up visits * Willing and able to undergo MR imaging. Exclusion Criteria: * Uncontrolled hypertension * Medically unstable coronary artery disease * Coagulopathy with inability to temporarily stop any antithrombotic medication * Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of abstinence etc.) * Unwilling or unable to undergo tremor surgery while awake * Significant and non-correctible motion artifact in imaging * Pregnant at the time of enrollment or preoperative evaluation * Dementia * History of psychosis * Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation * Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA * does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio ≤ 0.4 will be allowed for this study * Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation. * non-English speaking

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Conditions

The condition(s) this trial relates to.

essential tremor

As listed by the trial registrant

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

Essential tremor

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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