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Can a nerve graft in the brain boost the effects of deep brain stimulation for Parkinson's?

NCT ID NCT06683378

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This phase 1 trial tests whether implanting a small piece of a patient's own nerve tissue into the brain during standard deep brain stimulation (DBS) surgery can support brain cells and improve Parkinson's symptoms. Twenty-four adults with Parkinson's disease who are already scheduled for DBS will receive the nerve implant in one of two brain regions: the nucleus basalis of Meynert, which affects cognition, or the substantia nigra, which affects movement. Researchers will measure safety, feasibility, and changes in thinking, movement, daily activities, and quality of life over two years.

What this could mean

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

Active substance
Autologous peripheral nerve tissue implanted into the brain during deep brain stimulation surgery
What this could lead to
If it works, this could point toward a way to repair or support brain areas affected by Parkinson's disease, potentially improving both motor and non-motor symptoms beyond what DBS alone can achieve.
What could go wrong
This is an early, small phase 1 trial focused on safety and feasibility, so it may not show clear benefit. Risks include surgical complications from the nerve biopsy and brain implantation, and the procedure may not improve symptoms.

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 24 people

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

Started

Jul 2025

Expected to finish

May 2030

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 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 as defined by MDS criteria * Age 45-75, inclusive * 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 * Dementia diagnosis * Previous PD surgery or intracranial surgery * Unable to undergo an MRI * An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert

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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

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 Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

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