---
title: Increase time without involuntary movements
nct_id: NCT07635823
phase: NA
status: RECRUITING
sponsor: Beijing Pins Medical Co., Ltd
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07635823"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07635823"
last_fetched: "2026-06-14T14:07:28.063Z"
source: "Parkinson's Pathways (curated)"
---
# Increase time without involuntary movements

**Goal (in five words):** Increase time without involuntary movements

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

**Trial ID:** [NCT07635823](https://clinicaltrials.gov/study/NCT07635823)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Beijing Pins Medical Co., Ltd
- **Target Enrollment:** 60 participants
- **Start Date:** 2026-05-16
- **Completion Date:** 2027-05-31
- **Conditions:** Parkinson Disease(PD)
- **Interventions:** adaptive deep brain stimulation, conventional deep brain stimulation
- **Intervention Types:** DEVICE

## Summary For Families

The goal is to see if PINS Medical's rechargeable implanted closed-loop deep brain stimulation system (called G1010R) can increase daily time without troublesome involuntary movements, reduce periods when medication wears off, and improve movement, sleep, and overall quality of life. Participants will have the device surgically implanted and then try two ways of using it: adaptive closed-loop stimulation that automatically adjusts using real-time brain signals and sleep monitoring, and traditional continuous stimulation with fixed settings, with each person testing both options while blinded. The trial is looking for adults 18 and older with idiopathic Parkinson's whose symptoms are moderate to advanced when off medication (stage 2.5 to 4), either new candidates for bilateral stimulation surgery or existing bilateral stimulation patients with only one battery who respond to conventional therapy and agree to replace their device. Participants must be able to give written consent and complete all study visits and procedures.

## What This Actually Involves

**Placebo** _(From the protocol)_: This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.

**Visits** _(From the protocol)_: There are nine study visits across five trial phases.
  > "progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits."

**Procedures** _(From the protocol)_:
- Brain surgery / implanted device — Invasive
  > "adaptive deep brain stimulation"
- Surgical procedure — Invasive
  > "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."

**Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long.

**Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered.

_Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full Criteria

```
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
```

## Locations (9)

- The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, Anhui, China _(31.8639, 117.2808)_
  - Chaoshi Niu — (PRINCIPAL_INVESTIGATOR)
- Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China _(39.9075, 116.3972)_
  - Hutao Xie — (CONTACT) — +86 18756921517
  - Jianguo Zhang — (PRINCIPAL_INVESTIGATOR)
- Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China _(39.9075, 116.3972)_
  - Kailiang Wang — (CONTACT) — +86 13521539544
  - Guoguang Zhao — (PRINCIPAL_INVESTIGATOR)
- Peking Union Medical College Hospital, Beijing, Beijing Municipality, China _(39.9075, 116.3972)_
  - Yi Guo — (PRINCIPAL_INVESTIGATOR)
- First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China _(23.1167, 113.2500)_
  - Jinsheng Zeng — (PRINCIPAL_INVESTIGATOR)
  - Ling Chen — (SUB_INVESTIGATOR)
- Xiangya Hospital of Central South University, Changsha, Hunan, China _(28.1987, 112.9709)_
  - Zhiquan Yang — (PRINCIPAL_INVESTIGATOR)
- Nanjing Brain Hospital, Nanjing, Jiangsu, China _(32.0617, 118.7778)_
  - Chang Qiu — (CONTACT)
  - Wenbin Zhang — (PRINCIPAL_INVESTIGATOR)
- Qilu Hospital of Shandong University, Jinan, Shandong, China _(36.6683, 116.9972)_
  - Weiguo Li — (PRINCIPAL_INVESTIGATOR)
- West China Hospital, Chengdu, Sichuan, China _(30.6667, 104.0667)_
  - Wei Wang — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Jianguang Sun — (CONTACT) — +86 010-60736388 — sunjianguang@pinsmedical.com
- Qihang Shi — (CONTACT) — +86 18511837185 — shiqihang@pinsmedical.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07635823*  
*HTML version: https://parkinsonspathways.com/trial/NCT07635823*  
*Source data: https://clinicaltrials.gov/study/NCT07635823*