Parkinson's DiseasePhase 1STARNCT06683378
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
A Phase 1 study testing Reparative Autologous peripheral nerve tissue in people with Parkinson's Disease, run by Craig van Horne, MD, PhD at 1 site in United States.
Trial summary
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"… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Reparative Autologous peripheral nerve tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 28 May 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Group Monitored Email contact
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Jaimie Hixson, 859-323-1908, jaimie.henderson@uky.edu
About this study
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
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.
- Conditions
- Parkinson's Disease
- Being tested
- Reparative Autologous peripheral nerve tissue
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, DBS, Cell and Tissue Based Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reparative Autologous peripheral nerve tissueProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Peripheral nerve tissue (PNT) deployment to the Substantia Nigra | Active comparator | Not described Receives: Procedure: Reparative Autologous peripheral nerve tissue |
| Peripheral nerve tissue (PNT) deployment to the nucleus basalis of Meynert | Active comparator | Not described Receives: Procedure: Reparative Autologous peripheral nerve tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful deployment of bilateral peripheral nerve tissue (PNT) into the brain
Number of participants in each study arm who successfully receive bilateral PNT delivery.
Measured: Intraoperative
Number of participants completing 12 month study visit
Total number of participants to complete study visit by arm assignment
Measured: 12-month study visit
Study-related adverse events as assessed by MedDRA v27
Total number of study-related adverse events experienced by participants.
Measured: 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
Measured: Enrollment to 24-month study visit
Secondary outcomes (14)
PNT deployment attempts
Number of deployment attempts required, per participant, to deliver bilateral PNT by group allocation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline 6, 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start21 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion28 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig van Horne, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Craig van Horne, MD, PhD, University of Kentucky
- Investigators
- Craig G van Horne, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683378
- Sponsor's protocol ID
- 90066
- Other IDs
- 1R01AG081356-01A1
- Acronym
- STAR
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Daly SR, Quintero JE, Koehl L, Wallace E, Guduru Z, Gurwell JA, Hines T, Hixson J, Hulou S, Slevin JT, Schmitt FA, Gerhardt GA, van Horne CG. Autologous Peripheral Nerve Tissue Grafts Implanted into the Nucleus Basalis of Meynert and Substantia Nigra at the Time of Bilateral Deep Brain Stimulation in Parkinson Disease: A Report of 2 Cases. Neurosurg Pract. 2025 Dec 15;7(1):e000189. doi: 10.1227/neuprac.0000000000000189. eCollection 2026 Mar.
PubMed 41399615Ali S, Quintero JE, Richert M, Koehl L, Anderson-Mooney AJ, Gurwell JA, Manning KS, Hulou S, Hines T, Slevin JT, Gerhardt GA, Schmitt FA, van Horne CG. Implantation of autologous peripheral nerve tissue to the nucleus basalis of Meynert in patients with Parkinson's disease during deep brain stimulation surgery: a 2-year report of safety, feasibility, and clinical response. J Neurosurg. 2026 Aug 14:1-10. doi: 10.3171/2026.3.JNS251474. Online ahead of print.
PubMed 42600181Quintero 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 25.
PubMed 40007169van 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 2018 Feb 18.
PubMed 29451447Quintero 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.
PubMed 35949912
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06683378
- Acronym / sponsor ID
- STAR / 90066
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, DBS, Cell and Tissue Based Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Craig van Horne, MD, PhDUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 May 2030 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve tissue (PNT) deployment to the Substantia Nigra | Active comparator | Procedure: Reparative Autologous peripheral nerve tissue |
| Peripheral nerve tissue (PNT) deployment to the nucleus basalis of Meynert | Active comparator | Procedure: Reparative Autologous peripheral nerve tissue |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reparative Autologous peripheral nerve tissueAt 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). | Procedure or surgery | Peripheral nerve tissue (PNT) deployment to the Substantia Nigra, Peripheral nerve tissue (PNT) deployment to the nucleus basalis of Meynert |
Primary outcome
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.
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
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.
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
14 secondary outcomes
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
Number of participants completing 24-month study visit
Time frame: 24-month study visit
Mean change in Dementia Rating Scale (DSRS)
Time frame: Baseline 6, 12 and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 41399615Daly SR, Quintero JE, Koehl L, Wallace E, Guduru Z, Gurwell JA, Hines T, Hixson J, Hulou S, Slevin JT, Schmitt FA, Gerhardt GA, van Horne CG. Autologous Peripheral Nerve Tissue Grafts Implanted into the Nucleus Basalis of Meynert and Substantia Nigra at the Time of Bilateral Deep Brain Stimulation in Parkinson Disease: A Report of 2 Cases. Neurosurg Pract. 2025 Dec 15;7(1):e000189. doi: 10.1227/neuprac.0000000000000189. eCollection 2026 Mar.
- Background: PubMed 42600181Ali S, Quintero JE, Richert M, Koehl L, Anderson-Mooney AJ, Gurwell JA, Manning KS, Hulou S, Hines T, Slevin JT, Gerhardt GA, Schmitt FA, van Horne CG. Implantation of autologous peripheral nerve tissue to the nucleus basalis of Meynert in patients with Parkinson's disease during deep brain stimulation surgery: a 2-year report of safety, feasibility, and clinical response. J Neurosurg. 2026 Aug 14:1-10. doi: 10.3171/2026.3.JNS251474. Online ahead of print.
- Background: PubMed 40007169Quintero 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 25.
- Background: PubMed 29451447van 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 2018 Feb 18.
- Background: PubMed 35949912Quintero 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Group Monitored Email contact
Craig G van Horne, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reparative Autologous peripheral nerve tissue in people with Parkinson's Disease, run by Craig van Horne, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaimie Hixson (8593231908, jaimie.henderson@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful deployment of bilateral peripheral nerve tissue (PNT) into the brain (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683378, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.