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Remote Programming for Deep Brain Stimulation in Parkinson's Disease. (REPRO-PD)

Primary Purpose

Deep Brain Stimulation, Parkinson Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

remote programming

standard programming

About this trial

This is an interventional treatment trial for Deep Brain Stimulation focused on measuring telemedicine, remote programming

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 (SR1101) 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. Exclusion Criteria: 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.

Sites / Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the Remote Programming (RP) group

the Standard Programming (SP) group

Arm Description

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

After implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery

Outcomes

Primary Outcome Measures

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.

Cost-effectiveness

Quality Adjusted Life Years estimated by the cost and EQ-5D-3L.

Secondary Outcome Measures

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).

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.

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.

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.

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).

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.

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.

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.

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."

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.

Full Information

NCT ID

NCT06078397

First Posted

September 20, 2023

Last Updated

October 8, 2023

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06078397

Brief Title

Remote Programming for Deep Brain Stimulation in Parkinson's Disease.

Acronym

REPRO-PD

Official Title

Remote Programming for Deep Brain Stimulation in Parkinson's Disease: a Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 30, 2023 (Anticipated)

Primary Completion Date

January 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Brain Stimulation, Parkinson Disease

Keywords

telemedicine, remote programming

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the Remote Programming (RP) group

Arm Type

Experimental

Arm Description

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

Arm Title

the Standard Programming (SP) group

Arm Type

Active Comparator

Arm Description

After implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery

Intervention Type

Device

Intervention Name(s)

remote programming

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

standard programming

Intervention Description

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.

Primary Outcome Measure Information:

Title

The unified Parkinson's disease rating scale (UPDRS) Part III

Description

Time Frame

Preoperation and 6 months after surgery

Title

Cost-effectiveness

Description

Quality Adjusted Life Years estimated by the cost and EQ-5D-3L.

Time Frame

6 months after surgery

Secondary Outcome Measure Information:

Title

The unified Parkinson's disease rating scale (UPDRS) Part I, II and IV.

Description

Time Frame