Parkinson DiseaseNCT06919822
SCAN Targeted Epidural Modulation for Parkinson's Disease
A study testing Personalized SCAN Targeted Epidural Modulation in people with Parkinson Disease, run by Changping Laboratory at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if epidural modulation targeting the Somato-Cognitive Action Network (SCAN) can improve motor symptoms in adults with idiopathic Parkinson's disease (PD). It will also evaluate the safety of this treatment. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Personalized SCAN Targeted Epidural Modulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to May 2027
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic Parkinson's disease (PD) according to the revised clinical diagnostic criteria of the International Movement Disorder Society (MDS) (2015 version) or the Chinese Parkinson's Disease Diagnostic Criteria (2016 version).
- Age between 40 and 75 years, with a minimum age of 40 years at the time of diagnosis.
- Any gender, including both male and female patients.
- Hoehn-Yahr staging between 2 and 4 (inclusive).
- Disease duration of 5 years or more.
- Responding effectively to levodopa-based drug therapy with a minimum of 30% improvement in the levodopa loading test.
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- Presence of motor fluctuations with or without anisocoria despite optimal drug treatment.
- Stable on medication for at least the past 1 month prior to screening and surgery.
- Ability to understand the trial and willingness to sign an informed consent form.
Who cannot join
- Diagnosis of Parkinsonian superimposed syndrome or secondary Parkinson's disease.
- Presence of intracranial structural variants or other abnormalities that may interfere with TMS or surgical treatment, as detected by MRI or CT.
- Implantation of metallic medical devices such as deep brain stimulators, cochlear implants, vagus nerve stimulators, etc., which may affect MRI examination and TMS treatment.
- Contraindications to MRI scanning, including claustrophobia, tattoos, or magnetic metal-containing implants (to be confirmed with specialists).
- History of comorbid epilepsy or having first-degree relatives with a history of epilepsy.
- Receipt of other neuromodulation treatments (e.g., TMS, transcranial electrical stimulation, transcranial ultrasound stimulation) within the 1 months prior to enrollment.
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- Contraindications to neurosurgery, such as bleeding or coagulation disorders.
- Presence of severe organic diseases, including heart failure, renal failure, or malignancies.
- Cognitive impairment as indicated by MMSE score of 24 or below.
- Significant speech impairment, hearing impairment, or visual impairment that limits cooperation with testing.
- Severe depression (HAMD-17 score of 24 or above) or severe anxiety (HAMA score of 29 or above).
- Diagnosed psychiatric disorders based on DSM-V criteria or any psychological issues that may interfere with the study protocol.
- Alcohol or substance abuse.
- Active infections including hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, or human immunodeficiency virus (HIV) infection as determined by the investigator.
- Any other medical abnormalities deemed by the investigator to be unsuitable for participation in the trial.
- Inability to complete follow-up visits due to geographical or other reasons.
- Women of childbearing age who are pregnant, breastfeeding, or intend to become pregnant during the trial.
- Participation in other clinical trials concurrently.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Feng Wang, 15005018772, 15005018772@163.com
Yuanxiang Lin, MD
About this study
Official title: Somato-cognitive Action Network Targeted Epidural Modulation for Parkinson's Disease (STEM-PD): a Prospective Open-label Clinical Trial
The goal of this clinical trial is to learn if epidural modulation targeting the Somato-Cognitive Action Network (SCAN) can improve motor symptoms in adults with idiopathic Parkinson's disease (PD). It will also evaluate the safety of this treatment. The main questions it aims to answer are:
- Does epidural modulation targeting SCAN reduce motor symptoms (measured by MDS-UPDRS-III scores) in PD patients after 3 months?
- Is SCAN targeted epidural modulation (STEM) a safe and tolerable treatment for PD, with minimal adverse effects?
Read more
Researchers will compare participants' baseline motor function to their post-treatment results to determine if STEM is effective.
Participants will:
- First undergo non-invasive brain stimulation (iTBS) to test responsiveness.
- If eligible, receive surgical implantation of STEM electrodes in the personalized SCAN target.
- Complete follow-up visits for 12 months to monitor symptoms, side effects, and quality of life.
Read the detailed description
Background:
This is a prospective, open-label, single-center clinical trial investigating the efficacy and safety of personalized epidural modulation targeting the Somato-Cognitive Action Network (SCAN) in patients with idiopathic Parkinson's disease (PD). The study employs a two-stage intervention approach with comprehensive clinical and functional assessments. The study builds upon recent discoveries that the SCAN network shows preferential connectivity with PD-affected subcortical structures. By combining advanced neuroimaging for personalized target identification with staged therapeutic intervention, the trial aims to establish proof-of-concept for this novel neuromodulation approach. The design allows for initial non-invasive validation of target engagement through iTBS before proceeding to surgical implantation.
Study Design and Methodology:
The trial consists of two sequential stages:
- Screening and iTBS Intervention Stage (7 days) and a Washout Period (1-3 months): Eligible participants will first undergo intermittent theta-burst stimulation (iTBS) to their individualized SCAN target, identified through resting-state functional MRI and personalized-Brain-Functional-Sector (pBFS) mapping.
Participants demonstrating ≥30% improvement in motor symptoms proceed to a mandatory washout period.
Complete cessation of all neuromodulation therapies while maintaining stable PD medications.
- Surgical Intervention and Follow-up (12 months): Responsive patients undergo epidural electrode implantation over their predetermined SCAN target.
A scheduled12 months follow-up.
- Conditions
- Parkinson Disease
- Being tested
- Personalized SCAN Targeted Epidural Modulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized SCAN Targeted Epidural ModulationDevice
- Stage 1: iTBS Intervention (7 days) and Washout Period (1-3 months)
- All enrolled participants undergo:
- Baseline clinical assessments
- Structural and functional MRI with pBFS mapping
- Resting motor threshold determination
- Daily iTBS sessions targeting individualized SCAN coordinates:
- Treatment duration: 7 consecutive days
- Post-intervention evaluation at Day 7-14
- Mandatory observation window:
- No neuromodulation therapies permitted
- Stable PD medication regimen maintained
- Monthly safety monitoring
- Stage 2: Surgical Intervention and Follow-up (12 months)
- Surgical Procedure:
- Epidural electrode implantation
- Pulse generator internalization
- Epidural Modulation Stage:
- Parameter optimization visits
- Scheduled follow-ups at Months 1, 3, 6, 12
| Study group | Role | What they receive |
|---|---|---|
| Personalized STEM Intervention Arm | Experimental | This experimental arm involves a comprehensive two-stage therapeutic intervention for Parkinson's disease patients:
* Pre-surgical Screening Stage:
* All participants first undergo non-invasive intermittent theta-burst stimulation (iTBS) targeting their individualized Somato-Cognitive Action Network (SCAN) region.
* Surgical Intervention Stage (for iTBS responders):
* Patients showing ≥30% improvement in motor symptoms proceed to epidural implantation of electrodes over the predetermined SCAN target. Receives: Device: Personalized SCAN Targeted Epidural Modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III motor scores at 3 months post-stimulation（medication "off" state）
The change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination scores measured during the medication "off" state (after 12-hour overnight withdrawal of anti-Parkinson medications) from baseline to 3 months after initiating motor cortex stimulation. Higher scores indicate more severe motor impairment (range 0-132). A negative change indicates improvement.
Measured: Baseline to 3 months post-stimulation
Secondary outcomes (6)
Change in MDS-UPDRS-III scores (ON/OFF states) from baseline to 12 months
Difference in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination scores (range 0-132, higher=worse) between baseline and post-stimulation assessments during both medication ON (2 hours after levodopa dose) and OFF (after 12-hour withdrawal) states.
Measured: Baseline, 1-week, 1/3/6/12 months post-stimulation
Change in daily OFF time duration (hours) from baseline
Reduction in self-reported daily hours of OFF periods (time when Parkinson's medications are ineffective) as recorded in patient diaries, comparing baseline to post-stimulation timepoints.
Measured: Baseline, 1/3/6/12 months post-stimulation
Change in daily ON time duration (hours) from baseline
Increase in self-reported daily hours of good ON periods (medication effectiveness without troublesome dyskinesia) from baseline to follow-up assessments.
Measured: Baseline, 1/3/6/12 months post-stimulation
Change in 39-item Parkinson's Disease Questionnaire summary index score from baseline
Difference in 39-item Parkinson's Disease Questionnaire (PDQ-39) total score (range 0-100, higher=worse quality of life) between baseline and follow-up assessments.
Measured: Baseline, 1/3/6/12 months post-stimulation
Change in Clinical Global Impression (CGI) score from baseline
Improvement in clinician-rated CGI scale (range 1-7, higher=worse) assessing overall disease severity change since baseline.
Measured: Baseline, 1/3/6/12 months post-stimulation
Change in levodopa equivalent daily dose (LEDD) from baseline
Reduction in calculated total daily dopaminergic medication dosage (mg/day) while maintaining symptom control.
Measured: Baseline, 3/6/12 months post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start8 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, PhD, Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919822
- Sponsor's protocol ID
- STEM-PD
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somato-cognitive Action Network Targeted Epidural Modulation for Parkinson's Disease (STEM-PD): a Prospective Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT06919822
- Acronym / sponsor ID
- STEM-PD
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Apr 2025 (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 goal of this clinical trial is to learn if epidural modulation targeting the Somato-Cognitive Action Network (SCAN) can improve motor symptoms in adults with idiopathic Parkinson's disease (PD). It will also evaluate the safety of this treatment. The main questions it aims to answer are:
- Does epidural modulation targeting SCAN reduce motor symptoms (measured by MDS-UPDRS-III scores) in PD patients after 3 months?
- Is SCAN targeted epidural modulation (STEM) a safe and tolerable treatment for PD, with minimal adverse effects?
Researchers will compare participants' baseline motor function to their post-treatment results to determine if STEM is effective.
Participants will:
- First undergo non-invasive brain stimulation (iTBS) to test responsiveness.
- If eligible, receive surgical implantation of STEM electrodes in the personalized SCAN target.
- Complete follow-up visits for 12 months to monitor symptoms, side effects, and quality of life.
Detailed description
Background:
This is a prospective, open-label, single-center clinical trial investigating the efficacy and safety of personalized epidural modulation targeting the Somato-Cognitive Action Network (SCAN) in patients with idiopathic Parkinson's disease (PD). The study employs a two-stage intervention approach with comprehensive clinical and functional assessments. The study builds upon recent discoveries that the SCAN network shows preferential connectivity with PD-affected subcortical structures. By combining advanced neuroimaging for personalized target identification with staged therapeutic intervention, the trial aims to establish proof-of-concept for this novel neuromodulation approach. The design allows for initial non-invasive validation of target engagement through iTBS before proceeding to surgical implantation.
Study Design and Methodology:
The trial consists of two sequential stages:
- Screening and iTBS Intervention Stage (7 days) and a Washout Period (1-3 months): Eligible participants will first undergo intermittent theta-burst stimulation (iTBS) to their individualized SCAN target, identified through resting-state functional MRI and personalized-Brain-Functional-Sector (pBFS) mapping.
Participants demonstrating ≥30% improvement in motor symptoms proceed to a mandatory washout period.
Complete cessation of all neuromodulation therapies while maintaining stable PD medications.
- Surgical Intervention and Follow-up (12 months): Responsive patients undergo epidural electrode implantation over their predetermined SCAN target.
A scheduled12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized STEM Intervention Arm | Experimental | Device: Personalized SCAN Targeted Epidural ModulationThis experimental arm involves a comprehensive two-stage therapeutic intervention for Parkinson's disease patients: * Pre-surgical Screening Stage: * All participants first undergo non-invasive intermittent theta-burst stimulation (iTBS) targeting their individualized Somato-Cognitive Action Network (SCAN) region. * Surgical Intervention Stage (for iTBS responders): * Patients showing ≥30% improvement in motor symptoms proceed to epidural implantation of electrodes over the predetermined SCAN target. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with idiopathic Parkinson's disease (PD) according to the revised clinical diagnostic criteria of the International Movement Disorder Society (MDS) (2015 version) or the Chinese Parkinson's Disease Diagnostic Criteria (2016 version).
- Age between 40 and 75 years, with a minimum age of 40 years at the time of diagnosis.
- Any gender, including both male and female patients.
- Hoehn-Yahr staging between 2 and 4 (inclusive).
- Disease duration of 5 years or more.
Key exclusion criteria (18 listed)
- Diagnosis of Parkinsonian superimposed syndrome or secondary Parkinson's disease.
- Presence of intracranial structural variants or other abnormalities that may interfere with TMS or surgical treatment, as detected by MRI or CT.
- Implantation of metallic medical devices such as deep brain stimulators, cochlear implants, vagus nerve stimulators, etc., which may affect MRI examination and TMS treatment.
- Contraindications to MRI scanning, including claustrophobia, tattoos, or magnetic metal-containing implants (to be confirmed with specialists).
- History of comorbid epilepsy or having first-degree relatives with a history of epilepsy.
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 |
|---|---|---|
| Personalized SCAN Targeted Epidural Modulation* Stage 1: iTBS Intervention (7 days) and Washout Period (1-3 months) * All enrolled participants undergo: * Baseline clinical assessments * Structural and functional MRI with pBFS mapping * Resting motor threshold determination * Daily iTBS sessions targeting individualized SCAN coordinates: * Treatment duration: 7 consecutive days * Post-intervention evaluation at Day 7-14 * Mandatory observation window: * No neuromodulation therapies permitted * Stable PD medication regimen maintained * Monthly safety monitoring * Stage 2: Surgical Intervention and Follow-up (12 months) * Surgical Procedure: * Epidural electrode implantation * Pulse generator internalization * Epidural Modulation Stage: * Parameter optimization visits * Scheduled follow-ups at Months 1, 3, 6, 12 | Device | Personalized STEM Intervention Arm |
Primary outcome
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III motor scores at 3 months post-stimulation（medication "off" state）
Time frame: Baseline to 3 months post-stimulation
The change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination scores measured during the medication "off" state (after 12-hour overnight withdrawal of anti-Parkinson medications) from baseline to 3 months after initiating motor cortex stimulation. Higher scores indicate more severe motor impairment (range 0-132). A negative change indicates improvement.
6 secondary outcomes
Change in MDS-UPDRS-III scores (ON/OFF states) from baseline to 12 months
Time frame: Baseline, 1-week, 1/3/6/12 months post-stimulation
Change in daily OFF time duration (hours) from baseline
Time frame: Baseline, 1/3/6/12 months post-stimulation
Change in daily ON time duration (hours) from baseline
Time frame: Baseline, 1/3/6/12 months post-stimulation
Change in 39-item Parkinson's Disease Questionnaire summary index score from baseline
Time frame: Baseline, 1/3/6/12 months post-stimulation
Change in Clinical Global Impression (CGI) score from baseline
Time frame: Baseline, 1/3/6/12 months post-stimulation
Change in levodopa equivalent daily dose (LEDD) from baseline
Time frame: Baseline, 3/6/12 months post-stimulation
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 19 Feb 2026.
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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.
Hesheng Liu, PhD study chair
Changping Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized SCAN Targeted Epidural Modulation in people with Parkinson Disease, run by Changping Laboratory at 1 site in China.
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 9 inclusion and 18 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 19 Feb 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 China. 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.
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 Hesheng Liu, PhD (+86 13263297367, liuhesheng@cpl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III motor scores at 3 months post-stimulation（medication "off" state） (time frame: Baseline to 3 months post-stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2026.