Protect substantia nigra dopamine neurons
- Trial ID
- NCT06683378
- Official Title
- Phase I Randomized, Double-blind Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Nucleus Basalis of Meynert or Substantia Nigra for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery
- Goal
- Protect substantia nigra dopamine neurons
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Craig van Horne, MD, PhD
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- Parkinson's Disease
- Interventions
- Reparative Autologous peripheral nerve tissue
Plain-Language Summary
It aims to help the specific motor problems tied to the substantia nigra or the non-motor issues linked to the nucleus basalis of Meynert by giving local, reparative support to those brain regions. The team takes a small piece of your own peripheral nerve, usually the sural nerve, and implants that autologous tissue into the target area during your planned DBS surgery; the graft releases growth factors and supportive cells that may protect or help repair dying neurons, so it is intended to complement, not replace, levodopa or DBS. The trial is a phase 1 safety and feasibility study enrolling about 24 people. Eligible participants are age 45 to 75 with clinically established or probable Parkinsons who are already scheduled for DBS, can tolerate MRI and surgery, have an available sural nerve, and do not have dementia, prior brain surgery, or an obstructed surgical path.
Locations
- University of Kentucky, Lexington, Kentucky, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Reparative Autologous peripheral nerve tissue. It aims to help the specific motor problems tied to the substantia nigra or the non-motor issues linked to the nucleus basalis of Meynert by giving local, reparative support to those brain regions. The team takes a small piece of your own peripheral nerve, usually the sural nerve, and implants that autologous tissue into the target area during your planned DBS surgery; the graft releases growth factors and supportive cells that may protect or help repair dying neurons, so it is intended to complement, not replace, levodopa or DBS. The trial is a phase 1 safety and feasibility study enrolling about 24 people. Eligible participants are age 45 to 75 with clinically established or probable Parkinsons who are already scheduled for DBS, can tolerate MRI and surgery, have an available sural nerve, and do not have dementia, prior brain surgery, or an obstructed surgical path.
- Who can participate?
- Participants must be between 45 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 5 months.