A Phase 1 interventional study of Reparative Autologous peripheral nerve tissue in Parkinson's Disease, sponsored by Craig van Horne, MD, PhD. Recruiting at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Craig van Horne, MD, PhD · Phase 1, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Craig van Horne, MD, PhD is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Procedure: Reparative Autologous peripheral nerve tissue
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 Meynert (NBM) or substantia nigra (SN).
Successful deployment of bilateral peripheral nerve tissue (PNT) into the brain
Number of participants in each study arm who successfully receive bilateral PNT delivery.
Time frame: Intraoperative
Number of participants completing 12 month study visit
Total number of participants to complete study visit by arm assignment
Time frame: 12-month study visit
Study-related adverse events as assessed by MedDRA v27
Total number of study-related adverse events experienced by participants.
Time frame: Enrollment to 24-month study visit
Study-related serious adverse events as assessed by MedDRA v.27
Total number of serious adverse events experienced by participants
Time frame: Enrollment to 24-month study visit
PNT deployment attempts
Number of deployment attempts required, per participant, to deliver bilateral PNT by group allocation
Time frame: During surgery
Mean change in Montreal Cognitive Assessment (MoCA) scores
Mean change in MoCA scores for participants at study visits compared to baseline by group allocation. Assessment is scored from 0-30 with a score of 26 or better indicating normal cognition. A score less than 26 indicates a cognitive deficit.
Time frame: Baseline 6, 12 and 24 months after surgery
Mean change in Neuropsychological assessment scores
Participants complete a neuropsychological assessment battery that meets the Movement Disorder Society (MDS) guidelines for determining mild cognitive impairment/mild neurocognitive disorder. Domains include attention and working memory, executive functioning, memory (verbal and visual), language, and visuospatial skills. Participants' raw scores will be converted to standardized scores based on appropriate norms (e.g., age-based norms). Participants' 12 and 24-month re-evaluation will be compared to their baseline pre-surgical assessment to determine change from baseline on each measure. A change that exceeds 1.5 standard deviation from their baseline performance will be considered notable.
Time frame: Baseline, 12 and 24 months
Change in Neuropsychological diagnosis
Changes in participant neuropsychological diagnoses during scheduled evaluations will be reported. e.g. No cognitive diagnosis progressing to mild neurocognitive disorder.
Time frame: Baseline, 12 and 24 months
Change in Neuropsychological domains with impairment
A count of the number of domains with impairment at each study visit to compare with previous study visits.
Time frame: At 12, 24 months compared to baseline
Mean change in Modified Schwab and England Scale of Activities of Daily Living scores
Mean change participant independence levels as measured in Schwab and England Scale of Activities of Daily Living scores. 100% = completed independent and 0% being completely dependent.
Time frame: At 6, 12, 24 months compared to baseline
Mean change in Parkinson's Disease Questionnaire-8 (PDQ-8) quality of life scores
Assess changes in participant's quality of life. Questionnaire is scored from 0-32 with higher scores indicating poorer quality of life.
Time frame: At 12 and 24 months compared to baseline
Mean change in Non-motor symptom scale scores
Assessment used to identify Parkinson's disease related non-motor symptoms experienced by participants. The scale measures the frequency and severity of symptoms and is scored from 0-360 with higher scores indicating more frequent and severe symptoms.
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
MDS-UPDRS Part I scores non-motor symptoms effecting activities of daily living in those with Parkinson's Disease. Scores range from 0-52 with higher scores indicating greater symptom severity.
Time frame: 6, 12, and 24 months as compared to baseline
Mean change of the MDS-UPDRS Part II scores
MDS-UPDRS Part II scores motor symptoms effecting activities of daily living in those with Parkinson's Disease. Scores range from 0-52 with higher scores indicating greater symptom severity.
Time frame: At 6, 12, 24 months compared to baseline
Mean change in MDS-UPDRS Part III scores
MDS-UPDRS Part III scores motor symptoms associated with Parkinson's Disease. Part III scores range from 0-132 with higher scores indicating higher symptom severity.
Time frame: At 6, 12, 24 months compared to baseline
Mean change in MDS-UPDRS Part IV scores
MDS-UPDRS Part IV scores motor complications such as fluctuations and dyskinesia's associated with anti-Parkinson's medications. Scores range from 0-24 with higher scores indicating greater severity in motor complications.
Time frame: At 6, 12, and 24 months compared to baseline
Number of participants completing 24-month study visit
Total number of participants completing 24 month study visit by group allocation
Time frame: 24-month study visit
Mean change in Dementia Rating Scale (DSRS)
A survey to assess and rate changes the cognitive and behavioral functioning of participants. Scale is scored from 0-54 with being higher numbers indicating greater dementia severity.
Time frame: Baseline 6, 12 and 24 months after surgery
Plan to share: Yes — The focus of this study is PD, but images and results will be made available to other researchers by asking participants, at the time of consent, their willingness to permit sharing of data and bio-specimens.
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Craig van Horne, MD, PhD