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Could your own nerves help heal Parkinson's? small trial begins

NCT ID NCT05377281

Disease control Sponsor: Craig van Horne, MD, PhD 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This early-stage trial tests whether implanting a small piece of a patient's own nerve tissue into the brain during deep brain stimulation (DBS) surgery is safe and feasible. Ten people with Parkinson's disease will receive the implant, and researchers will monitor them for a year. The goal is to see if the procedure can be done successfully without major complications.

What this could mean

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

Active substance
patient's own peripheral nerve tissue (sural nerve)
What this could lead to
If successful, this could point toward a new way to repair brain damage in Parkinson's disease using the patient's own tissue.
What could go wrong
This is a very early, small trial with only 10 people, focused on safety and feasibility. It may not show any benefit, and there are risks from surgery and nerve biopsy.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

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

Started

Jul 2022

Expected to finish

Jun 2027

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

40 to 75 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: * Undergoing DBS * Diagnosis of clinically established or clinically probably PD (Parkinson's disease) as defined by MDS criteria * Age 40-75, inclusive * Able and willing to undergo ioflupane/SPECT * Able to tolerate the surgical procedure * Able to undergo all planned assessments * Available access to the sural nerve Exclusion Criteria: * Any condition that would not make the subject a candidate for DBS * Previous PD surgery or intracranial surgery * Typical, nonparkinsonian syndrome ioflupane/SPECT signal * Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study * Unable to undergo an MRI * An obstructed trajectory path to the substantia nigra

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

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

Parkinson's disease

Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

More trials for these conditions

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