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New brain stimulation device shows promise for Parkinson's patients

NCT ID NCT05992701

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new deep brain stimulation (DBS) system that uses directional leads to treat Parkinson's disease. 26 adults with Parkinson's whose symptoms were not well controlled by medication took part. The goal was to see if the system could improve motor function and quality of life while having a wider safety margin between helpful stimulation and side effects.

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

26 people

The number who actually took part.

Started

Jul 2021

Finished

Dec 2023

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 to 75 years

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: 1. Age at the time of enrollment: 18 \~ 75; 2. Idiopathic Parkinson's disease; 3. Patient whose symptoms are not adequately controlled by best medical therapy; 4. Hoehn and Yahr stage≥2.5; 5. Patient whose symptoms are improved by at least 30% with levodopa challenge test; 6. Must be an appropriate candidate for the surgical procedures required for bilateral DBS; 7. Is willing and able to comply with all visits and study related procedures; 8. Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Exclusion Criteria: 1. Had received lesioning surgical treatment; 2. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception; 3. Any current drug or alcohol abuse; 4. Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above); 5. Any significant psychiatric problems, including unrelated clinically significant depression; 6. Any history of craniocerebral injury, tumor, or severe cerebrovascular disease; 7. Severe brain atrophy (confirmed by CT or MRI); 8. A condition requiring or likely to require the use of diathermy; 9. Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function; 10. Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases; 11. Long-term of immunosuppressive or hormone therapy; 12. Other diseases requiring the stimulators; 13. A condition requiring or likely to require the use of MRI; 14. Participated in any other clinical trials within the preceding 3 months; 15. Unwilling or unable to cooperate with the implantation of DBS system; 16. Unwilling or unable to cooperate with postoperative follow-up; 17. Not considered to be applicable by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, China

  • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University

    Beijing, China

  • Changhai Hospital, the Second Military Medical University

    Shanghai, China

  • First Affiliated Hospital of Kunming Medical University

    Kunming, China

  • Nanjing Brain Hospital Affiliated to Nanjing Medical University

    Nanjing, China

  • Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)

    Shenzhen, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • West China Hospital of Sichuan University

    Chengdu, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, China

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