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New treatment option for Parkinson Disease
Official title SCAN Targeted Epidural Modulation for Parkinson's Disease
ClinicalTrials.gov ID: NCT06919822
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Diagnosed with idiopathic Parkinson's disease (PD) according to the revised clinical diagnostic criteria of the International Movement Disorder...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.