Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
Recruiting
Phase 1Interventional Study
Multiple System AtrophyParkinsons Disease
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At a Glance
Age
40 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
7 (estimated)
Sponsor
Craig van Horne, MD, PhD · Other
Who this trial is looking for
This trial is looking for people diagnosed with Parkinson's disease or Multiple System Atrophy. Participants will have a small nerve graft surgery and will be monitored for a year to see how it affects their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease or Multiple System Atrophy.
I have had my condition for more than 2 years.
I am between 40 and 75 years old.
I have a moderate score on a specific Parkinson's disease scale.
I can tolerate the surgical procedure.
I can go through all planned assessments.
I have access to my sural nerve.
You may not be able to join if
I have had previous surgery for Parkinson's disease or brain surgery.
I have a major medical or psychiatric disorder.
I take certain antipsychotic medications.
I cannot undergo an MRI.
I have significant cardiovascular issues.
I take anticoagulants other than aspirin.
I am pregnant, breastfeeding, or not using birth control.
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?
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This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participant…
This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
* Disease duration greater than 2 years
* Age 40-75, inclusive
* MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or eq…
Inclusion Criteria:
* Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
* Disease duration greater than 2 years
* Age 40-75, inclusive
* MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
* No MDS-UPDRS Part III score \>3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
* Able and willing to undergo ioflupane/SPECT
* Able to tolerate the surgical procedure
* Able to undergo all planned assessments
* Available access to the sural nerve
Exclusion Criteria:
* Previous PD surgery or intracranial surgery
* Ongoing major medical or psychiatric disorder incl. depression and psychosis
* Other concomitant treatment with neuroleptics
* Typical, nonparkinsonian syndrome ioflupane/SPECT signal
* Unable to undergo an MRI
* An obstructed trajectory path to the substantia nigra
* Significant microvascular disease
* Use of anticoagulants other than aspirin
* Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
* Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study.
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