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NCT Number: 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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Jaimie Hixson

CONTACT

[email protected]

859-323-1908

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reparative Autologous peripheral nerve tissue

Procedure

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).

Primary outcomes

  1. Successful deployment of bilateral peripheral nerve tissue (PNT) into the brain

    Time frame: Intraoperative

    Number of participants in each study arm who successfully receive bilateral PNT delivery.

  2. Number of participants completing 12 month study visit

    Time frame: 12-month study visit

    Total number of participants to complete study visit by arm assignment

  3. Study-related adverse events as assessed by MedDRA v27

    Time frame: Enrollment to 24-month study visit

    Total number of study-related adverse events experienced by participants.

  4. Study-related serious adverse events as assessed by MedDRA v.27

    Time frame: Enrollment to 24-month study visit

    Total number of serious adverse events experienced by participants

Secondary outcomes

  1. PNT deployment attempts

    Time frame: During surgery

    Number of deployment attempts required, per participant, to deliver bilateral PNT by group allocation

  2. Mean change in Montreal Cognitive Assessment (MoCA) scores

    Time frame: Baseline 6, 12 and 24 months after surgery

    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.

  3. Mean change in Neuropsychological assessment scores

    Time frame: Baseline, 12 and 24 months

    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.

  4. Change in Neuropsychological diagnosis

    Time frame: Baseline, 12 and 24 months

    Changes in participant neuropsychological diagnoses during scheduled evaluations will be reported. e.g. No cognitive diagnosis progressing to mild neurocognitive disorder.

  5. Change in Neuropsychological domains with impairment

    Time frame: At 12, 24 months compared to baseline

    A count of the number of domains with impairment at each study visit to compare with previous study visits.

  6. 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 participant independence levels as measured in Schwab and England Scale of Activities of Daily Living scores. 100% = completed independent and 0% being completely dependent.

  7. Mean change in Parkinson's Disease Questionnaire-8 (PDQ-8) quality of life scores

    Time frame: At 12 and 24 months compared to baseline

    Assess changes in participant's quality of life. Questionnaire is scored from 0-32 with higher scores indicating poorer quality of life.

  8. Mean change in Non-motor symptom scale scores

    Time frame: At 12 and 24 months compared to baseline

    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.

  9. 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

    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.

  10. Mean change of the MDS-UPDRS Part II scores

    Time frame: At 6, 12, 24 months compared to baseline

    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.

  11. Mean change in MDS-UPDRS Part III scores

    Time frame: At 6, 12, 24 months compared to baseline

    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.

  12. Mean change in MDS-UPDRS Part IV scores

    Time frame: At 6, 12, and 24 months compared to baseline

    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.

  13. Number of participants completing 24-month study visit

    Time frame: 24-month study visit

    Total number of participants completing 24 month study visit by group allocation

  14. Mean change in Dementia Rating Scale (DSRS)

    Time frame: Baseline 6, 12 and 24 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Group Monitored Email

CONTACT

[email protected]

Jaimie Hixson

CONTACT

[email protected]

8593231908

Sponsors and collaborators

Lead sponsor

Craig van Horne, MD, PhD

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study 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

Acronym: STAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Nov 12, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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