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Recruiting NCT06683378

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 Interventional Parkinson's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reparative Autologous peripheral nerve tissue.
Who it may be relevant to
Registry conditions: Parkinson's Disease. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Reparative Autologous peripheral nerve tissue
    At the time participants are receiving the standard of care deep brain stimulation (DBS) surgery, a standard incision on the lateral aspect near the ankle is made, the sural nerve is identified, an about 3 cm biopsy of the sural nerve is obtained and the incision is closed. From the biopsied section, the epineurium is removed, fascicles are cut, and (\~5 pieces per side; \~ 5mm length x 1.5 mm diameter: approximately 10 cubic millimeters) implanted bilaterally into the nucleus basalis of Meyner

Primary outcome measures

  • Successful deployment of bilateral peripheral nerve tissue (PNT) into the brain [Time frame: Intraoperative]
  • Number of participants completing 12 month study visit [Time frame: 12-month study visit]
  • Study-related adverse events as assessed by MedDRA v27 [Time frame: Enrollment to 24-month study visit]
  • Study-related serious adverse events as assessed by MedDRA v.27 [Time frame: Enrollment to 24-month study visit]
Secondary outcome measures (12)
  • PNT deployment attempts [Time frame: During surgery]
  • Mean change in Montreal Cognitive Assessment (MoCA) scores [Time frame: Baseline 6, 12 and 24 months after surgery]
  • Mean change in Neuropsychological assessment scores [Time frame: Baseline, 12 and 24 months]
  • Change in Neuropsychological diagnosis [Time frame: Baseline, 12 and 24 months]
  • Change in Neuropsychological domains with impairment [Time frame: At 12, 24 months compared to baseline]
  • Mean change in Modified Schwab and England Scale of Activities of Daily Living scores [Time frame: At 6, 12, 24 months compared to baseline]
  • Mean change in Parkinson's Disease Questionnaire-8 (PDQ-8) quality of life scores [Time frame: At 12 and 24 months compared to baseline]
  • Mean change in Non-motor symptom scale scores [Time frame: At 12 and 24 months compared to baseline]
  • Mean change of the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Part I scores [Time frame: 6, 12, and 24 months as compared to baseline]
  • Mean change of the MDS-UPDRS Part II scores [Time frame: At 6, 12, 24 months compared to baseline]
  • Mean change in MDS-UPDRS Part III scores [Time frame: At 6, 12, 24 months compared to baseline]
  • Mean change in MDS-UPDRS Part IV scores [Time frame: At 6, 12, and 24 months compared to baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Publications

  • Quintero JE, Chau MJ, Slevin JT, Koehl L, Gurwell JA, Wallace E, Kryscio RJ, El Khouli R, Anderson-Mooney AJ, Schmitt FA, Gerhardt GA, van Horne CG. Two-year feasibility and safety of open-label autologous peripheral nerve tissue implantation during deep brain stimulation in patients with Parkinson's disease. J Parkinsons Dis. 2025 Mar;15(2):397-408. doi: 10.1177/1877718X241312409. Epub 2025 Feb 2 PMID 40007169
  • van Horne CG, Quintero JE, Slevin JT, Anderson-Mooney A, Gurwell JA, Welleford AS, Lamm JR, Wagner RP, Gerhardt GA. Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up study of safety, feasibility, and clinical outcome. J Neurosurg. 2018 Dec 1;129(6):1550-1561. doi: 10.3171/2017.8.JNS163222. Epub 2 PMID 29451447
  • Quintero JE, Slevin JT, Gurwell JA, McLouth CJ, El Khouli R, Chau MJ, Guduru Z, Gerhardt GA, van Horne CG. Direct delivery of an investigational cell therapy in patients with Parkinson's disease: an interim analysis of feasibility and safety of an open-label study using DBS-Plus clinical trial design. BMJ Neurol Open. 2022 Jul 14;4(2):e000301. doi: 10.1136/bmjno-2022-000301. eCollection 2022. PMID 35949912

Identifiers

NCT: NCT06683378 · 90066 · 1R01AG081356-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗