Idiopathic Parkinson PatientsPhase 1NCT02937727
MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients
A Phase 1 study testing 3T MRI compatible and LFP recordable G106R of Beijing Pins medical. in people with Idiopathic Parkinson Patients, run by Beijing Pins Medical Co., Ltd at 3 sites in China.
Trial summary
Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Parkinson Patients
- What is being tested?
- 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2016to Mar 2018
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18，≤75，idiopathic Parkinson's disease，both male and female
- MMSE score ≥24
- H-Y score ≥2.0 on the medicine off situation
- UPDRS-III score≥30 on the medicine off situation
- The duration of this disease ≥5 years
- Ability to provide informed consent as determined by preoperative neuropsychological assessment
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- History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients
- Excellent responsiveness to levodopa
- ≥6h in medicine off state
Who cannot join
- Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
- Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia
- Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases
- Patients who are unable to follow verbal instructions
- Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
Trial locations and contacts
3 sites in 1 country.
Fumin Jia, PhD contact
Luming Li, PhD contact
China3 sites, 3 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Jianguo Zhang, MD, 010-67096611, Limuxin2011@163.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Wenbin Ma, MD, 010-69152530
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Shujun Xu, MD, 0531-82166631, xu-shujunql@163.com
About this study
Official title: Evaluate the Safety and Effectiveness of 3T MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients
Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. New Approaches in MRI at 3T and long-term local field potential (LFP) recording are very important to target subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term clinical and electrophysiology effects of deep brain stimulation on STN.
- Conditions
- Idiopathic Parkinson Patients
- Being tested
- 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRI compatible and LFP recordable G106R of Beijing Pins medical.Device
| Study group | Role | What they receive |
|---|---|---|
| MRI compatible and LFP recordable implantable stimulator | Experimental | Not described Receives: Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS part III
Measured: 1 month,3 months, 6 months and 12months
Local Field Potential Recordings using G106R
Measured: 1 month,3 months, 6 months and 12months
Secondary outcomes (4)
UPDRS part III
Measured: 1, 3 months of stimulation
UPDRS part II
Measured: 1, 3 months stimulation
Levodopa Equivalent Dose
Drug Therapy are definied as levodopa equivalent dose,which is devodopa containing or dopamine agonist containing medications
Measured: 1, 3 months stimulation
Local Field Potential Recordings using G106R
Measured: 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson PatientsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937727
- Sponsor's protocol ID
- PINS-021
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Zhang G, Yu H, Chen Y, Gong C, Hao H, Guo Y, Xu S, Zhang Y, Yuan X, Yin G, Zhang JG, Tan H, Li L. Neurophysiological features of STN LFP underlying sleep fragmentation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2024 Nov 18;95(12):1112-1122. doi: 10.1136/jnnp-2023-331979.
PubMed 38724231
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Effectiveness of 3T MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients
- ClinicalTrials.gov ID
- NCT02937727
- Acronym / sponsor ID
- PINS-021
- Conditions
- Idiopathic Parkinson Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- 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.
Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. New Approaches in MRI at 3T and long-term local field potential (LFP) recording are very important to target subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term clinical and electrophysiology effects of deep brain stimulation on STN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI compatible and LFP recordable implantable stimulator | Experimental | Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18，≤75，idiopathic Parkinson's disease，both male and female
- MMSE score ≥24
- H-Y score ≥2.0 on the medicine off situation
- UPDRS-III score≥30 on the medicine off situation
- The duration of this disease ≥5 years
Key exclusion criteria (5 listed)
- Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
- Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia
- Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases
- Patients who are unable to follow verbal instructions
- Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
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 |
|---|---|---|
| 3T MRI compatible and LFP recordable G106R of Beijing Pins medical. | Device | MRI compatible and LFP recordable implantable stimulator |
Primary outcome
UPDRS part III
Time frame: 1 month,3 months, 6 months and 12months
Local Field Potential Recordings using G106R
Time frame: 1 month,3 months, 6 months and 12months
4 secondary outcomes
UPDRS part III
Time frame: 1, 3 months of stimulation
UPDRS part II
Time frame: 1, 3 months stimulation
Levodopa Equivalent Dose
Time frame: 1, 3 months stimulation
Local Field Potential Recordings using G106R
Time frame: 1 month, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Derived from this study: PubMed 38724231Zhang G, Yu H, Chen Y, Gong C, Hao H, Guo Y, Xu S, Zhang Y, Yuan X, Yin G, Zhang JG, Tan H, Li L. Neurophysiological features of STN LFP underlying sleep fragmentation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2024 Nov 18;95(12):1112-1122. doi: 10.1136/jnnp-2023-331979.
- Individual participant dataSharing planned: Yes
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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.
Fumin Jia, PhD contact
Luming Li, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3T MRI compatible and LFP recordable G106R of Beijing Pins medical. in people with Idiopathic Parkinson Patients, run by Beijing Pins Medical Co., Ltd at 3 sites 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 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: status not confirmed, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fumin Jia, PhD (010-60736388), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS part III (time frame: 1 month,3 months, 6 months and 12months). The study lists 2 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 NCT02937727, which also lists 1 linked publication.
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 23 Jun 2017.