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
Recruiting
Phase 1Interventional Study
Parkinson's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Craig van Horne, MD, PhD · Other
Who this trial is looking for
This trial is looking for people with Parkinson's Disease who are scheduled to have deep brain stimulation (DBS) surgery. Participants will receive a treatment involving nerve tissue during their surgery and will be monitored for changes in their health over time.
Are You a Good Fit for This Trial?
You may be able to join if
I am undergoing deep brain stimulation (DBS).
I have been diagnosed with Parkinson's Disease.
I am between 45 and 75 years old.
I can tolerate the surgical procedure.
I can complete the planned assessments.
I have access to the sural nerve.
You may not be able to join if
I have a condition that would prevent me from having DBS.
I have been diagnosed with dementia.
I have had previous surgery for Parkinson's Disease.
I have had any previous intracranial surgery.
I cannot undergo an MRI.
There is an obstructed path to my brain's substantia nigra.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 (…
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.
Trial Locations
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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:
* An…
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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