Adaptive DBS for PD
ConditionParkinson Disease(PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Pins Medical Co., Ltd
About this trial
The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
idiopathic Parkinson's disease
Hoehn & Yahr (HY) stage 2.5-4 during medication "OFF"
Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
Disqualifiers
Presence of contraindications to deep brain stimulation (DBS) surgery.
Beck Depression Inventory-II (BDI-II) score > 25
Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level)
Significant comorbidities that may interfere with DBS therapy per investigator assessment.
Trial design
Design model
Crossover
Treatments tested in this trial
adaptive deep brain stimulation
Deviceadaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device. aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms.
conventional deep brain stimulation
Deviceconventional deep brain stimulation is a common stimulation mode that has been used for years. It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
In the Motor-Sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The Motor-Sleep Diary was collected at both the cDBS treatment and aDBS treatment during the crossover evaluation phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
Time frame
about one month each after randomizationOther outcomes
1
Motor-sleep dairy
In the Motor-sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The Motor-sleep Diary also collects a visual analogue scale that subjects use to evaluate overall quality of sleep last night. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The Motor-sleep Diary was collected at the cDBS treatment and aDBS treatment during crossover evaluation phases. Motor-sleep Diary collects 5 measurements: 1. daily "On" time without troublesome dyskinesia 2. daily "On" time with troublesome dyskinesia 3. daily "Off" time 4. daily asleep time 5. quality of sleep The result of 2 type of treatments and baseline will be compared.
Time frame
about one month after randomization2
MDS UPDRS
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) contains 4 parts. Each parts range as the following: 0\~52, 0\~52, 0\~132, 0\~24. Lower score means better rating on the according symptoms. Each measures different perspective of motor disorder. In this trial, 5 measurements will be collected: 1. MDS UPDRS part I 2. MDS UPDRS part II ("best" condition) 3. MDS UPDRS part II ("worst" condition) 4. MDS UPDRS part III 5. MDS UPDRS part IV Each measurements will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.
Time frame
about one month after randomization3
PDSS-2
Parkinson's Disease Sleep Scale 2(PDSS-2) measures the quality of sleep of Parkinson's Disease. The scale ranges from 0 to 60. Lower score means better rating on sleep conditions. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.
Time frame
about one month after randomization4
PSQI
Pittsburgh sleep quality index(PSQI) measures the quality of sleep. The scale ranges from 0 to 21. Lower score means better rating on the quality of sleep. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.
Time frame
about one month after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Pins Medical Co., Ltd
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Nanjing Brain Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
West China Hospital
Collaborator
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Collaborator
Peking Union Medical College Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Source ClinicalTrials.gov