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Brain implant that thinks for itself could transform Parkinson's care

NCT ID NCT07635823

Disease control Sponsor: Beijing Pins Medical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new type of deep brain stimulation (DBS) that automatically adjusts its settings based on real-time brain signals, unlike standard DBS which uses fixed stimulation. Sixty people with Parkinson's disease will have a special neurostimulator implanted and then experience both the adaptive and conventional modes in a randomized, double-blind crossover design. The goal is to see if the adaptive system improves daily 'on' time without troublesome movement side effects, motor symptoms, and quality of life compared to the standard approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adaptive deep brain stimulation (aDBS) device
What this could lead to
If successful, this could offer Parkinson's patients a more personalized treatment that automatically adjusts stimulation to their needs, potentially improving symptom control and quality of life.
What could go wrong
This is a relatively small, early-stage trial (60 people) comparing two device modes, not a new drug. The benefits may be modest, and not everyone may respond well to the adaptive mode.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Dyskinesias Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease (PD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 10000, China

  • First Affiliated Hospital, Sun Yat-Sen University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Nanjing Brain Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Peking Union Medical College Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, Shandong, China

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    NOT_YET_RECRUITING

    Hefei, Anhui, China

  • West China Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 10000, China

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