Implanting nerve tissue into the brain for Parkinson's and Multiple System Atrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I double-blind clinical trial investigates the safety and feasibility of implanting autologous peripheral nerve tissue into the substantia nigra of patients diagnosed with Parkinson's disease or Multiple System Atrophy. The study will enroll 7 participants, with 4 receiving the nerve graft and 3 undergoing a sham surgery. Participants will be early in their diagnosis with less severe symptoms, and the trial aims to assess the potential for nerve tissue to repair damaged brain cells and slow disease progression. Follow-up will occur for one year post-surgery to evaluate outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Craig van Horne, MD, PhD — University of Kentucky
• Study coordinator: Jaimie Hixson
• Email: jaimie.henderson@uky.edu
• Phone: 859-323-1908

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Longitudinal registry of people with multiple system atrophy in China

  This study follows Chinese patients with multiple system atrophy over time to describe how the disease starts and progresses and to compare with people with Parkinson's and healthy controls.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07644013

• Personalized magnetic brain stimulation for parkinsonian disorders

  This study will try personalized repetitive transcranial magnetic stimulation (rTMS) to see if it eases motor and non-motor symptoms in people with Parkinson's disease, multiple system atrophy, or progressive supranuclear palsy.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07570212

• Using AI to find facial and speech signs of Parkinson's and related disorders

  This project uses AI to analyze facial expressions and speech to try to find digital markers that help diagnose and tell apart Parkinson's disease, PSP, MSA, and healthy people.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07392411

• Evaluating a new PET imaging agent for brain conditions

  This study is testing a new imaging agent to see if it can help detect certain brain changes in people with Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies, as well as in healthy individuals.

  Recruiting Early Phase 1 Massachusetts General Hospital · Charlestown, Massachusetts · NCT06098612

• Ginger as a Modifier of Ghrelin Levels in Parkinson’s Disease and REM Sleep Behavior Disorder

  This study tests whether ginger capsules can raise ghrelin levels in people with Parkinson’s disease, REM sleep behavior disorder, and healthy controls.

  Recruiting Cambridge University Hospitals NHS Foundation Trust · Cambridge · NCT07882108

• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

  This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.