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Clinical efficacy study of a closed-loop deep b rain stimulation for advanced Parkinson's disease

Clinical efficacy study of a closed-loop deep b rain stimulation for advanced Parkinson's disease - Clinical efficacy study of a closed-loop deep b rain stimulation for advanced Parkinson's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042900
Enrollment
50
Registered
2021-09-01
Start date
2021-08-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&#39

Interventions

Sponsors

Department of Neurosurgery, Osaka University Graduate School of Medicine
Lead Sponsor
Otemae Hospital Osaka General Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: He has been diagnosed with Parkinson's disease. The diagnosis is based on the diagnostic criteria proposed by the International Parkinson and Movement Disorder Society (MDS) in 2015. An implantable pulse generator capable of performing closed-loop stimulation has been implanted. Deep brain stimulation electrodes have been implanted in the bilateral subthalamic nuclei or in the globus pallidus interna for at least six months. The age at the time of consent is 20 years or older. Cognitive function is maintained to the extent that the research schedule and tasks can be understood, and informed consent can be given.

Exclusion criteria

Exclusion criteria: Patients for whom evaluation after a 12-hour drug washout is unsafe. Patients who have diseases other than Parkinson's disease that may affect the evaluation of neurological function. Other patients who are judged by the attending physician to be difficult to participate in this study.

Design outcomes

Primary

MeasureTime frame
Amount of Change in PDQ-39 Score

Secondary

MeasureTime frame
Change in MDS-UPDRS total score Change in MDS-UPDRS subgroup score Change in Timed Up and Go Change in Berg Balance Scale Frequency and severity of stimulation side effects

Countries

Japan

Contacts

Public ContactNaoki Tani

Osaka University Graduate School of Medicine Department of Neurosurgery

n-tani@nsurg.med.osaka-u.ac.jp+81-6-6879-3652

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026