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Brain Implant's hidden impact on voice and swallowing in Parkinson's

NCT ID NCT07026734

Knowledge-focused Sponsor: University of Florida 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study looks at how deep brain stimulation (DBS) — a surgical treatment for Parkinson's disease — affects voice, swallowing, and cough. Researchers will compare two common DBS targets (GPi and STN) to see which one better preserves these functions. One hundred people with Parkinson's who are already scheduled for DBS surgery will be tested before and after the procedure.

What this could mean

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

Active substance
deep brain stimulation (DBS) surgery targeting either the globus pallidus internal segment (GPi) or the subthalamic nucleus (STN)
What this could lead to
If it succeeds, this study could help doctors choose the best DBS target for each patient to minimize side effects on voice, swallowing, and cough.
What could go wrong
This is an observational study, not a treatment trial, so it will not directly test a new therapy. Results may not lead to immediate changes in clinical practice.

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 100 people

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

Started

May 2025

Expected to finish

May 2029

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

45 to 85 years

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 idiopathic (non-genetic/familial) PD made by fellowship-trained neurologist by applying strict UK brain bank criteria Hoehn \& Yahr staging I - IV Approved for DBS surgery to either STN or GPi, with NO existing DBS electrodes. Mild or moderate voice / swallow problems Exclusion Criteria: Neurological disorder(s) other than PD (including essential tremor) Severe neuropsychological dysfunction, unstable psychiatric disease at the discretion of the treating neurologist/psychiatrist (i.e., severe depression) or moderate to severe cognitive impairment. History of: * Head, neck, or lung cancer (except minor squamous cell skin cancers) * Structural, functional, or neurologic voice disorder unrelated to PD * Chronic refractory cough * Bleeding disorder

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Conditions

The condition(s) this trial relates to.

Parkinson disease Speech

As listed by the trial registrant

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

Parkinson disease, idiopathic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Florida, Norman Fixel Institute for Neurological Diseases

    RECRUITING

    Gainesville, Florida, 32611, United States

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