Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06683378 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery
A Phase 1 study of Parkinson's Disease, sponsored by Craig van Horne, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06683378: Recruiting Phase 1 study of Parkinson's Disease, sponsored by Craig van Horne, MD, PhD.
NCT06683378 is a Phase 1 study of Parkinson's Disease that is actively recruiting participants, run by Craig van Horne, MD, PhD. The registered enrollment target is 24 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06683378, a Phase 1 study of Parkinson's Disease, is actively recruiting participants, sponsored by Craig van Horne, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of participants in each study arm who successfully receive bilateral PNT delivery.
Conditions Studied
Interventions
- PROCEDURE Reparative Autologous peripheral nerve tissue
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-07-21 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 1 |
What NCT06683378 shows while recruiting
NCT06683378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Reparative Autologous peripheral nerve tissue is the first listed.
NCT06683378 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT06683378 about?
NCT06683378 is a clinical study titled "A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery". 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 ...
What is the current status of trial NCT06683378?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-07-21. Estimated completion is 2028-02-28.
What conditions does trial NCT06683378 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT06683378?
The interventions under investigation include: Reparative Autologous peripheral nerve tissue (PROCEDURE).
Who is sponsoring clinical trial NCT06683378?
This trial is sponsored by Craig van Horne, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06683378 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06683378's enrollment target sits among peer trials
24 119th of 158 higher than 38 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
rTMS to Improve Cognition in Parkinson's
RECRUITING · Phase 1
-
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
RECRUITING · Phase 1
-
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
RECRUITING · Phase 1
-
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
RECRUITING · Phase 1
-
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
RECRUITING · Phase 1
-
Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI