Adaptive DBS for PD (SMART-DBS)
keskiviikko 17. kesäkuuta 2026 päivittänyt: Beijing Pins Medical Co., Ltd
Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
The goal of this clinical trial is to evaluate the efficacy and safety of PINS Medical's rechargeable implantable closed-loop deep brain stimulation (aDBS) system for improving quality of life in Parkinson's disease patients.
Researchers will compare adaptive closed-loop stimulation (which automatically adjusts therapy using real-time brain signals) against conventional open-loop stimulation (cDBS) in a prospective, multicenter, double-blind, randomized crossover study.
Participants will undergo surgical implantation of the neurostimulator system and progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits.
During crossover testing, each participant will experience both stimulation modes sequentially while blinded.
Key outcomes include duration of troublesome/non-troublesome dyskinesia, "off" time, sleep scales (VAS, PDSS-2, PSQI), motor symptoms (MDS-UPDRS), quality of life (PDQ-39, EQ-5D-5L), and safety parameters.
The primary analysis will occur after all randomized subjects complete crossover testing and unblinding (Visit 7).
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
60
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Jianguang Sun
- Puhelinnumero: +86 010-60736388
- Sähköposti: sunjianguang@pinsmedical.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Qihang Shi
- Puhelinnumero: +86 18511837185
- Sähköposti: shiqihang@pinsmedical.com
Opiskelupaikat
-
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Anhui
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Hefei, Anhui, Kiina
- Ei vielä rekrytointia
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
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Päätutkija:
- Chaoshi Niu
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina
- Ei vielä rekrytointia
- Peking Union Medical College Hospital
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Päätutkija:
- Yi Guo
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Beijing, Beijing Municipality, Kiina, 10000
- Rekrytointi
- Beijing Tiantan Hospital, Capital Medical University
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Päätutkija:
- Jianguo Zhang
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Ottaa yhteyttä:
- Hutao Xie
- Puhelinnumero: +86 18756921517
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Beijing, Beijing Municipality, Kiina, 10000
- Rekrytointi
- Xuanwu Hospital, Capital Medical University
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Ottaa yhteyttä:
- Kailiang Wang
- Puhelinnumero: +86 13521539544
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Päätutkija:
- Guoguang Zhao
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Guangdong
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Guangzhou, Guangdong, Kiina
- Ei vielä rekrytointia
- First Affiliated Hospital, Sun Yat-Sen University
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Päätutkija:
- Jinsheng Zeng
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Alatutkija:
- Ling Chen
-
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Hunan
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Changsha, Hunan, Kiina
- Rekrytointi
- Xiangya Hospital of Central South University
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Päätutkija:
- Zhiquan Yang
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Jiangsu
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Nanjing, Jiangsu, Kiina
- Rekrytointi
- Nanjing Brain Hospital
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Ottaa yhteyttä:
- Chang Qiu
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Päätutkija:
- Wenbin Zhang
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Shandong
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Jinan, Shandong, Kiina
- Ei vielä rekrytointia
- Qilu Hospital of Shandong University
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Päätutkija:
- Weiguo Li
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Sichuan
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Chengdu, Sichuan, Kiina
- Ei vielä rekrytointia
- West China Hospital
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Päätutkija:
- Wei Wang
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Inclusion Criteria:
- idiopathic Parkinson's disease
- Hoehn & Yahr (HY) stage 2.5-4 during medication "OFF"
Subjects must meet one of the following:
- Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
- Previous bilateral STN/GPi DBS recipients with only one IPG who:
- Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
- Consent to device replacement with G1010R DBS system.
- Willing and physically/mentally able to complete all study visits and procedures
- Capable of comprehending and providing written informed consent
Exclusion Criteria:
- 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.
- Pre-existing active non-DBS medical implants or metallic cranial implants
- Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period
- History of ablative neurosurgery or stem cell therapy for Parkinson's disease
- Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries
- Inability to maintain prescribed medication regimens or comply with protocol requirements
- Current pregnancy, lactation, or planned pregnancy during the study period
- Other conditions deemed by investigators to compromise study suitability
- Participation in other interventional clinical trials within 4 weeks prior to consent
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Group A
Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.
|
adaptive 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.
Muut nimet:
conventional 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.
Muut nimet:
|
|
Kokeellinen: Group B
Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.
|
adaptive 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.
Muut nimet:
conventional 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
Aikaikkuna: about one month each after randomization
|
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.
|
about one month each after randomization
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Motor-sleep dairy
Aikaikkuna: about one month after randomization
|
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:
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about one month after randomization
|
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Recharging DBS Experience
Aikaikkuna: about one month after randomization
|
Recharging DBS Experience measures the experience of subject recharge DBS device under each treatment.
It is evaluated by recharging interval and accumulation of electric energy depletion.
The numeric results are calculated using DBS recharging dairy embedded in the device.
The more frequently recharge or the more electric energy is depleted, the poor experience the subjects have.
The measurements will be collected for each treatment during crossover phase and will be compared.
|
about one month after randomization
|
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TEED
Aikaikkuna: about one month after randomization
|
Total Electric Energy Delivered(TEED) measures the amount of energy consumed by stimulation for each treatment.
The numeric result are estimated by DBS stimulation parameters.
The measurements will be collected for each treatment during crossover phase and will be compared.
|
about one month after randomization
|
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Peripheral Device Measurements
Aikaikkuna: about one month after randomization
|
Peripheral device measurements include motor and sleep metrics that can offer extra symptom analysis.
The measurements will be collected for each treatment during crossover phase and will be compared.
|
about one month after randomization
|
|
GIC
Aikaikkuna: about 14 days after programming during adjustment phase
|
The Global Impression Change Score(GIC) measure the acceptance of each treatment after programming compared to the previous treatment.
It is evaluated by subject using effectiveness and side effect to acquire a status code that can be analyzed descriptively.
The measurements will be collected for each treatment during adjustment phase and will be compared.
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about 14 days after programming during adjustment phase
|
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MDS UPDRS
Aikaikkuna: about one month after randomization
|
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:
The result of each treatment will be compared. |
about one month after randomization
|
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PDSS-2
Aikaikkuna: about one month after randomization
|
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.
|
about one month after randomization
|
|
PSQI
Aikaikkuna: about one month after randomization
|
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.
|
about one month after randomization
|
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PDQ-39
Aikaikkuna: about 6 months after randomization
|
Parkinson's Disease Questionnaire-39(PDQ-39) measures the quality of life of Parkinson's Disease, containing 39 items that range from 0 to 4. The final score is computed through the following steps: 1. calculate the average score of every item in 8 dimensions and span the results to a range from 0 to 100; 2. calculate the average score of all dimensions.
The final score ranges from 0 to 100.
Lower score means better rating on the quality of life.
Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover.
The result of each treatment will be compared.
Overall result will be analyzed descriptively.
|
about 6 months after randomization
|
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EQ-5D-5L
Aikaikkuna: about 6 months after randomization
|
EQ-5D-5L measures the quality of life, containing 5 questions and 1 visual analogue scale(VAS) for rating of subjective conclusive quality of life.
The results of 5 questions form a state code of 5 digits.
The state code will be transformed to EQ-5D index score using a values set for China.
Measurements will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover.
The results of each treatment will be compared.
Overall result will be analyzed descriptively.
|
about 6 months after randomization
|
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Patient Preference Questionnaire
Aikaikkuna: about 2 months after randomization
|
Patient Preference Questionnaire measures the preference to each treatments while blinded.
The questionnaire contains 6 independent questions.
Each option of every question will be counted as a percentage.
Measurement will be collected at the end of last crossover phase before unblinding.
The result of each treatment will be compared and analyzed descriptively.
|
about 2 months after randomization
|
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Patient Satisfaction Questionnaire
Aikaikkuna: about 6 months after randomization
|
Patient Satisfaction Questionnaire measures the satisfaction with each treatments.
The questionnaire contains 3 independent questions.
Each option of every question will be counted as a percentage.
Measurement will be collected at the end of entire trial before completion.
The result of each treatment will be compared and analyzed descriptively.
|
about 6 months after randomization
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Yhteistyökumppanit ja tutkijat
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Yhteistyökumppanit
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