Deep Brain StimulationREPRO-PDNCT06078397
Remote Programming for Deep Brain Stimulation in Parkinson's Disease.
A study testing remote programming and standard programming in people with Deep Brain Stimulation and Parkinson Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to conduct a randomized controlled study to compare the efficacy of remote programming (RP) on the improvement of motor function after DBS surgery in PD patients with standard programming (SP). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Brain Stimulation, Parkinson Disease
- What is being tested?
- remote programming and standard programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 30 Jun 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult primary Parkinson's disease patients who meet the diagnostic criteria for Parkinson's disease in China (2016 edition), aged 18-75 years
- Comply with the surgical indications of the "Expert Consensus on Deep Brain Stimulation Therapy for Parkinson's Disease in China (Second Edition)" and complete bilateral STN-DBS surgery
- Accurate lead position verified by postoperative CT examination
- The implanted DBS device has remote programming function
- Having an internet connection at home or in the area that will receive remote postoperative management, and being able to participate in remote symptom assessment and remote programming
- Able to communicate fluently, and after education, I and my caregivers are proficient in using the patient client of the remote program control system
- Understand potential risks/benefits, agree to participate in the study, study procedures, agree to complete the study follow-up, and comply with the requirements of the study protocol.
Who cannot join
- The preoperative concise mental state examination (MMSE) score of DBS indicates moderate or above cognitive impairment
- Severe complications after DBS surgery, such as stroke, encephalitis, wound infection, etc.
- Lack of cooperation, or inability to understand the experimental plan or provide informed consent for any reason
- Unable to provide stable network signal or unable to provide 4 × 1.5 m space for motion evaluation
- Other researchers believe that factors may not be suitable for research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Dianyou Li, MD, PhD, ldy11483@rjh.com.cn
About this study
Official title: Remote Programming for Deep Brain Stimulation in Parkinson's Disease: a Randomized Controlled Study
This study aims to conduct a randomized controlled study to compare the efficacy of remote programming (RP) on the improvement of motor function after DBS surgery in PD patients with standard programming (SP).
Read the detailed description
This is a randomized controlled trial aiming at comparing the efficacy of RP and SP in post-operative management of PD patients with DBS. Enrolled patients will be randomly assigned to the RP or SP groups before surgery. After recording baseline data, regular programming sessions will be conducted through RP or SP. Patients will be followed up in 6 months after implantation, with the main goal of the differences in motor symptom improvement between the two groups and the secondary goal of the difference in safety and economic benefits between both methods.
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Being tested
- remote programming, standard programming
- Keywords
- telemedicine, remote programming
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote programmingDevice
Remote programming (RP) is a new type of patient management method after DBS surgery, which allows physicians to understand the patient's movement symptoms and adjust parameters through video conferencing. At the same time, the RP system also includes device checks, medication adjustments, psychological counseling, and other contents. Compared to standard programming that requires going to the hospital, the application of RP can save the burden on patients and their caregivers.
standard programmingDevice
Programming refers to a series of methods that set the parameters of the IPG after the implantation of DBS, and adjust the device parameters based on the patient's symptoms during subsequent follow-up to maintain the efficacy of electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| the Remote Programming (RP) group | Experimental | After implantation of DBS and train for RP in hospital, regularly receive RP instead of in-visit SP for parameter adjustment in 1, 3, 6 month after surgery Receives: Device: remote programming |
| the Standard Programming (SP) group | Active comparator | After implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery Receives: Device: standard programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
The unified Parkinson's disease rating scale (UPDRS) Part III
The unified Parkinson's disease rating scale (UPDRS) Part III is made up of motor examinations (18 items). Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). Score range: 0-132, 32 and below is mild, 59 and above is severe.
Measured: Preoperation and 6 months after surgery
Cost-effectiveness
Quality Adjusted Life Years estimated by the cost and EQ-5D-3L.
Measured: 6 months after surgery
Secondary outcomes (10)
The unified Parkinson's disease rating scale (UPDRS) Part I, II and IV.
The unified Parkinson's disease rating scale (UPDRS) is made up of these sections:
Part I: Nonmotor experiences of daily living: 13 items. Score range: 0-52, 10 and below is mild, 22 and above is severe.
Part II: Motor experiences of daily living: 13 items. Score range: 0-52, 12 and below is mild, 30 and above is severe.
Part III: Motor examinations :18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.
Part IV: Motor complications: 6 items. Score range: 0-24, 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
Measured: Preoperation and 6 months after surgery.
Parkinson's Disease Questionaire-8 (PDQ-8)
The Parkinson's Disease Questionaire-8 (PDQ-8) is an eight-question instrument with questions taken from each domain of 39-item Parkinson's Disease Questionnaire (PDQ-39). Each question is scored between 0 and 4, higher scores indicate poorer quality of life.
Measured: Preoperation and 6 months after surgery.
European Quality of Life 5 Dimensions 3 Level Version
The European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Preoperation and 6 months after surgery.
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory (BDI-II) is a widely used 21-item self-report inventory measuring the severity of depression in adolescents and adults. Each item is scored between 0 and 3, a score of 10 to 18 indicates mild depression, and 30 or above indicates severe depression.
Measured: Preoperation and 6 months after surgery.
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI) is a self-report inventory measuring 21 common somatic and cognitive symptoms of anxiety. Each item is scored by a Likert scale ranging from 0 to 3 and raw scores ranging from 0 to 63, classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).
Measured: Preoperation and 6 months after surgery.
Mini-Mental State Examination (MMSE)
A Mini-Mental State Examination (MMSE) is a set of 11 questions with scores ranging from 0~30 points used to check for cognitive impairment (problems with thinking, communication, understanding and memory). Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Measured: Preoperation and 6 months after surgery.
Cost of patients' perspective
Costs of patients and caregivers' perspective were taken into account: a.travel, b. informal care and c. income loss (calculated by time). Costs was collected by unified questionnaires.
Measured: 6 months after surgery.
Telehealth Satisfaction Survey (TeSS)
Telehealth Satisfaction Survey (TeSS) is a 10-item scale for Satisfaction scores on the, Each response was rated as poor, fair, good and excellent (0 to 3). Higher scores indicated higher satisfaction with telehealth.
Measured: Collected within 2 days (48 hours) after each programming.
The Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: Collected within 2 days (48 hours) after each programming.
Safety: Rate of programming related adverse events
The adverse events questionnaire is composed of 3 parts: 1.Hardware related (eg. Poor Internet connection); 2. Operation related (eg. Low battery of devices); 3.Stimulation related (eg. Dyskinesia after programming); 4. Others.
Measured: Collected within 2 days (48 hours) after each programming.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start30 Oct 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jun 2025 (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 Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078397
- Sponsor's protocol ID
- RPDBSPD
- Acronym
- REPRO-PD
- Status last verified
- Aug 2023
- First submitted
- 20 Sep 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wan X, Zhou Y, Huang P, Pan Y, Lin Z, Zeng Z, Tan Y, Zhang C, Shotbolt P, Li D. Remote programming versus standard in-person programming following deep brain stimulation in patients with Parkinson's disease: a randomised controlled trial. EClinicalMedicine. 2026 Jul 9;97:104070. doi: 10.1016/j.eclinm.2026.104070. eCollection 2026 Jul.
PubMed 42472285
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Programming for Deep Brain Stimulation in Parkinson's Disease: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06078397
- Acronym / sponsor ID
- REPRO-PD / RPDBSPD
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Keywords
- telemedicine, remote programming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Oct 2023 (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.
This study aims to conduct a randomized controlled study to compare the efficacy of remote programming (RP) on the improvement of motor function after DBS surgery in PD patients with standard programming (SP).
Detailed description
This is a randomized controlled trial aiming at comparing the efficacy of RP and SP in post-operative management of PD patients with DBS. Enrolled patients will be randomly assigned to the RP or SP groups before surgery. After recording baseline data, regular programming sessions will be conducted through RP or SP. Patients will be followed up in 6 months after implantation, with the main goal of the differences in motor symptom improvement between the two groups and the secondary goal of the difference in safety and economic benefits between both methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Remote Programming (RP) group | Experimental | Device: remote programmingAfter implantation of DBS and train for RP in hospital, regularly receive RP instead of in-visit SP for parameter adjustment in 1, 3, 6 month after surgery |
| the Standard Programming (SP) group | Active comparator | Device: standard programmingAfter implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult primary Parkinson's disease patients who meet the diagnostic criteria for Parkinson's disease in China (2016 edition), aged 18-75 years
- Comply with the surgical indications of the "Expert Consensus on Deep Brain Stimulation Therapy for Parkinson's Disease in China (Second Edition)" and complete bilateral STN-DBS surgery
- Accurate lead position verified by postoperative CT examination
- The implanted DBS device has remote programming function
- Having an internet connection at home or in the area that will receive remote postoperative management, and being able to participate in remote symptom assessment and remote programming
Key exclusion criteria (5 listed)
- The preoperative concise mental state examination (MMSE) score of DBS indicates moderate or above cognitive impairment
- Severe complications after DBS surgery, such as stroke, encephalitis, wound infection, etc.
- Lack of cooperation, or inability to understand the experimental plan or provide informed consent for any reason
- Unable to provide stable network signal or unable to provide 4 × 1.5 m space for motion evaluation
- Other researchers believe that factors may not be suitable for research.
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 |
|---|---|---|
| remote programmingRemote programming (RP) is a new type of patient management method after DBS surgery, which allows physicians to understand the patient's movement symptoms and adjust parameters through video conferencing. At the same time, the RP system also includes device checks, medication adjustments, psychological counseling, and other contents. Compared to standard programming that requires going to the hospital, the application of RP can save the burden on patients and their caregivers. | Device | the Remote Programming (RP) group |
| standard programmingProgramming refers to a series of methods that set the parameters of the IPG after the implantation of DBS, and adjust the device parameters based on the patient's symptoms during subsequent follow-up to maintain the efficacy of electrical stimulation. | Device | the Standard Programming (SP) group |
Primary outcome
The unified Parkinson's disease rating scale (UPDRS) Part III
Time frame: Preoperation and 6 months after surgery
The unified Parkinson's disease rating scale (UPDRS) Part III is made up of motor examinations (18 items). Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). Score range: 0-132, 32 and below is mild, 59 and above is severe.
Cost-effectiveness
Time frame: 6 months after surgery
Quality Adjusted Life Years estimated by the cost and EQ-5D-3L.
10 secondary outcomes
The unified Parkinson's disease rating scale (UPDRS) Part I, II and IV.
Time frame: Preoperation and 6 months after surgery.
Parkinson's Disease Questionaire-8 (PDQ-8)
Time frame: Preoperation and 6 months after surgery.
European Quality of Life 5 Dimensions 3 Level Version
Time frame: Preoperation and 6 months after surgery.
Beck Depression Inventory (BDI-II)
Time frame: Preoperation and 6 months after surgery.
Beck Anxiety Inventory (BAI)
Time frame: Preoperation and 6 months after surgery.
Mini-Mental State Examination (MMSE)
Time frame: Preoperation and 6 months after surgery.
Cost of patients' perspective
Time frame: 6 months after surgery.
Telehealth Satisfaction Survey (TeSS)
Time frame: Collected within 2 days (48 hours) after each programming.
The Patient Global Impression of Change (PGIC)
Time frame: Collected within 2 days (48 hours) after each programming.
Safety: Rate of programming related adverse events
Time frame: Collected within 2 days (48 hours) after each programming.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 42472285Wan X, Zhou Y, Huang P, Pan Y, Lin Z, Zeng Z, Tan Y, Zhang C, Shotbolt P, Li D. Remote programming versus standard in-person programming following deep brain stimulation in patients with Parkinson's disease: a randomised controlled trial. EClinicalMedicine. 2026 Jul 9;97:104070. doi: 10.1016/j.eclinm.2026.104070. eCollection 2026 Jul.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote programming and standard programming in people with Deep Brain Stimulation and Parkinson Disease, run by Ruijin Hospital 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 7 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 22 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dianyou Li, MD, PhD ((021)64370045, ldy11483@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The unified Parkinson's disease rating scale (UPDRS) Part III (time frame: Preoperation and 6 months after surgery). 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 NCT06078397, 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 22 Feb 2024.