Parkinson Disease DementiaNCT06494956
To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease
A study testing Implant device in people with Parkinson Disease Dementia, run by Jiangsu CED Medtech Co., Ltd.
Trial summary
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease Dementia
- What is being tested?
- Implant device
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:1. Aged 18-70 years old, patients with primary Parkinson's disease;2. The duration of Parkinson's disease is 5 years or more;3. The stage of Hoehn-Yahr in the "off" (without medication) state is 2 or more stages;4. UPDRS motion score ≥30 in "Off" state;5. Good response to dopamine drugs, acute levodopa experiment UPDRS exercise score improvement rate of more than 30% (experimental drug Medoba 250mg);6. The daily drug shutdown period is at least 6 hours, or there are sports complications such as serious transactions, and repeated adjustments of drugs still cannot be effectively improved;7. MMSE score ≥24 points on the simple intelligent mental state Examination Scale;8. Have the ability of independent external charging operation;9. Patients or their family members can fully understand the treatment and sign informed consent;10. The patient had good compliance and was able to meet the requirements of postoperative follow-up.
Exclusion Criteria:1. Have received surgical treatment for Parkinson's disease other than deep brain stimulation, such as stereotactic destruction, cell transplantation, gamma knife, etc.;2. The "off" state has serious language disorders, dysphagia, balance disorders and other midline symptoms;3. There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, ventricle enlargement, cerebrovascular sequelae, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases;4. Have other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other neurostimulator, or need to undergo frequent magnetic examinations;5. Patients who are abnormally sensitive to temperature or allergic to heat;6. There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indicators exceeding three times the normal value).7. Patients with anxiety and depression.
About this study
Official title: A Prospective, Single-center, Open Clinical Study to Evaluate the Safety of Implantable Rechargeable Computerized Deep Nerve Stimulation Systems in Patients With Primary Parkinson's Disease
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease
Read the detailed description
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease
- Conditions
- Parkinson Disease Dementia
- Being tested
- Implant device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant deviceProcedure or surgery
A subcutaneous tunnel was established under general anesthesia, the electrode was connected to the stimulator, and the pulse generator was implanted in the skull.
| Study group | Role | What they receive |
|---|---|---|
| Single unit | Experimental | An implantable computer fills the deep nervous system and turns it on for treatment Receives: Procedure: Implant device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary
Subjects fill in diary cards
Measured: 7 months
Subjects fill in a diary card after device implantation
Subjects fill in diary cards
Measured: 6 months
Drug dosage evaluation
Subjects fill in diary cards
Measured: 7 months
Charging performance evaluation
Subjects fill in diary cards
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease DementiaStudies 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
- Jiangsu CED Medtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494956
- Sponsor's protocol ID
- CER-A-PG-01
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Open Clinical Study to Evaluate the Safety of Implantable Rechargeable Computerized Deep Nerve Stimulation Systems in Patients With Primary Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06494956
- Acronym / sponsor ID
- CER-A-PG-01
- Conditions
- Parkinson Disease Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Jiangsu CED Medtech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 10 Jul 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.
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease
Detailed description
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single unit | Experimental | Procedure: Implant deviceAn implantable computer fills the deep nervous system and turns it on for treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Implant deviceA subcutaneous tunnel was established under general anesthesia, the electrode was connected to the stimulator, and the pulse generator was implanted in the skull. | Procedure or surgery | Single unit |
Primary outcome
Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary
Time frame: 7 months
Subjects fill in diary cards
Subjects fill in a diary card after device implantation
Time frame: 6 months
Subjects fill in diary cards
Drug dosage evaluation
Time frame: 7 months
Subjects fill in diary cards
Charging performance evaluation
Time frame: 6 months
Subjects fill in diary cards
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Implant device in people with Parkinson Disease Dementia, run by Jiangsu CED Medtech Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary (time frame: 7 months). 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?
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 10 Jul 2024.