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RecruitingPhase 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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether placing a person's own nerve tissue into the brain is safe, can be done, and may help Parkinson's symptoms. It is for people with Parkinson's disease who are already approved for and have chosen deep brain stimulation (DBS), surgery that uses electrical signals in the brain. The nerve tissue will be placed in one of two brain areas during 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 "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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are having deep brain stimulation (DBS) surgery.
  • Have confirmed or probable Parkinson's disease under the study's diagnosis rules.
  • Are 45 to 75 years old.
  • Can safely go through the surgery.
  • Can complete all planned study tests.
  • Have a sural nerve, a nerve in the leg, that can be reached for tissue collection.

Who can't join

  • Have any condition that makes DBS surgery unsuitable.
  • Have been diagnosed with dementia, a condition that affects memory and thinking.
  • Have had surgery for Parkinson's disease or surgery inside the skull.
  • Cannot have an MRI scan.
  • Have a blocked surgical path to the study's brain targets: the substantia nigra and nucleus basalis of Meynert.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

KY