Recruiting
Phase 1

PNT with DBS

Sponsor:

Craig van Horne, MD, PhD

Code:

NCT06683378

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Reparative Autologous peripheral nerve tissue

Study Details

Brief summary:

The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.

Conditions

Parkinson's Disease

Study ID

NCT06683378

Start date

Jul 21, 2025

Status verified date

Aug, 2026

Completion date

May 28, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Peripheral nerve tissue (PNT) deployment to the Substantia Nigra

active comparator: Peripheral nerve tissue (PNT) deployment to the nucleus basalis of Meynert

Interventions

Reparative Autologous peripheral nerve tissue

At the time participants are receiving the standard of care deep brain stimulation (DBS) surgery, a standard incision on the lateral aspect near the ankle is made, the sural nerve is identified, an about 3 cm biopsy of the sural nerve is obtained and the incision is closed.

From the biopsied section, the epineurium is removed, fascicles are cut, and (\~5 pieces per side; \~ 5mm length x 1.5 mm diameter: approximately 10 cubic millimeters) implanted bilaterally into the nucleus basalis of Meynert (NBM) or substantia nigra (SN).

Primary outcome measure

  • Successful deployment of bilateral peripheral nerve tissue (PNT) into the brain [ Time Frame: Intraoperative ]
  • Number of participants completing 12 month study visit [ Time Frame: 12-month study visit ]
  • Study-related adverse events as assessed by MedDRA v27 [ Time Frame: Enrollment to 24-month study visit ]
  • Study-related serious adverse events as assessed by MedDRA v.27 [ Time Frame: Enrollment to 24-month study visit ]

Central Contacts and Locations

Central contacts

Jaimie Hixson

8593231908jaimie.henderson@uky.edu

Group Monitored Email

nervegraft@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Jaimie Hixson

859-323-1908jaimie.henderson@uky.edu

More Information

Sponsor

Craig van Horne, MD, PhD

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Parkinson's Disease
  • Deep Brain Stimulation
  • DBS
  • Cell and Tissue Based Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Craig van Horne, MD, PhD on 2026-08-31.