New brain stimulation device shows promise for Parkinson's patients
NCT ID NCT05992701
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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26 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Dec 2023
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Beijing Tiantan Hospital, Capital Medical University
Beijing, China
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Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Beijing, China
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Changhai Hospital, the Second Military Medical University
Shanghai, China
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First Affiliated Hospital of Kunming Medical University
Kunming, China
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Nanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing, China
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Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
Shenzhen, China
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Tianjin Medical University General Hospital
Tianjin, China
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West China Hospital of Sichuan University
Chengdu, China
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Zhongnan Hospital of Wuhan University
Wuhan, China
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Other studies related to the condition(s) this trial covers.
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- A genetic roadmap for Parkinson's: testing thousands to unlock clues
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- Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.