Recruiting · registry status

Testing a brain stimulator that adapts to changing signals

Researchers compare a responsive brain stimulation system with another approach, checking safety and control of Parkinson’s symptoms.

Testing a treatment or activity · Study reference: NCT07635823

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date): 2026-05-16
Main measurements finished (planned): 2027-05-31
Study finished (planned): 2027-09-30

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 18 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * idiopathic Parkinson's disease * Hoehn \& Yahr (HY) stage 2.5-4 during medication "OFF" * Subjects must meet one of the following: 1. Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery; 2. 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

Full study name & original research details

Official study title

Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial

Short title used by the registry

Adaptive DBS for PD

Original description

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.

Further description from the registry

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).

Conditions reported: Parkinson Disease(PD)

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT07635823 ↗ — RECRUITING; checked 2026-10-11
ClinicalTrials.gov · NCT07635823 ↗ — Recruiting; WHO ICTRP processed 2026-06-29; checked 2026-10-11

Study type: Interventional
Interventions: adaptive deep brain stimulation; conventional deep brain stimulation
Phases: NA
Sponsor: Beijing Pins Medical Co., Ltd
Start date reported by registry: 2026-05-16 (actual)

Registry updated: 2026-06-22 · Status last verified by the registry submitter: 2026-06

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Jianguang Sun · +86 010-60736388 · sunjianguang@pinsmedical.com

Qihang Shi · +86 18511837185 · shiqihang@pinsmedical.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

Not yet recruiting

Chaoshi Niu

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Recruiting

Hutao Xie · +86 18756921517

Jianguo Zhang

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Recruiting

Kailiang Wang · +86 13521539544

Guoguang Zhao

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Not yet recruiting

Yi Guo

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Not yet recruiting

Jinsheng Zeng

Ling Chen

Xiangya Hospital of Central South University

Changsha, Hunan, China

Recruiting

Zhiquan Yang

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Recruiting

Chang Qiu

Wenbin Zhang

Qilu Hospital of Shandong University

Jinan, Shandong, China

Not yet recruiting

Weiguo Li

West China Hospital

Chengdu, Sichuan, China

Not yet recruiting

Wei Wang

Facility not reported

China

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.