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Not yet recruitingNCT05959161Updated Jul 25, 2023

Study on Brain Network Mechanism of Deep Brain Stimulation for Parkinson's Disease

An observational study in Parkinson Disease, Deep Brain Stimulation and Non-motor Symptoms, sponsored by Tianjin Huanhu Hospital. Not yet recruiting. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-25.

Sponsored by Tianjin Huanhu Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
Up to 75 Years
Sex
All
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Study summary

As a surgical intervention, DBS can effectively relieve PD tremor, rigidity, bradykinesia and other symptoms. How to better screen patients suitable for DBS treatment and conduct reasonable preoperative and postoperative evaluation is crucial to judge the treatment effect and prognosis. The clinical symptom evaluation of PD patients can be divided into motor symptom evaluation and non-motor symptom evaluation. The motor symptoms of PD patients were evaluated by UPDRS III. The evaluation of non-motor symptoms in PD patients was mainly divided into three aspects: cognitive status, emotional status, and sleep status. Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) were used to assess the cognitive status of PD patients. The Hamilton Depression Scale (HAMD) was used to assess the patients' depression status. The Hamilton Anxiety Scale (HAMA) was used to assess the patients' anxiety status. The PD Sleep Scale 2nd version, The PD Sleep Scale 2nd version, PDSS - 2), and rem Sleep Behavior Disorder Questionnaire (sweet HK) (Rapid Eye Movement Sleep behaviors Disorder Questionnaire - Hong Kong, RBDQ - HK) to assess Sleep conditions.

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Conditions studied

  • Parkinson Disease
  • Deep Brain Stimulation
  • Non-motor Symptoms

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03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's planned enrollment of 100 is close to the median of 97 across 1,081 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Tianjin Huanhu Hospital is the lead sponsor of 26 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with primary Parkinson's disease were followed up for 1 year after deep brain stimulation, and the imaging data were intact

Eligibility criteria

Inclusion Criteria:The clinical diagnosis of PD is consistent with the United Kingdom Parkinson's Disease Society Brain Bank criteria, with disease duration over 5 years, age under 75, acute levodopa motor response ≥30%, and indication for STN-DBS. -

Exclusion Criteria: patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery -

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • improvement and no improvement

    We observed whether the symptoms of patients improved after DBS surgery and divided them into groups.

    Procedure: DBS

  • imp+ and imp-

    Procedure: DBS

Interventions

  • ProcedureDBS

    We observed the prognostic changes of patients after DBS surgery

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What researchers measure

Primary outcomes

  1. motor symptom

    UPDRS III score changes

    Time frame: 2023.1 to 2025.12

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2023; primary completion for Sep 2026, 37 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2023
First posted
Jul 25, 2023
StartEst.
Aug 1, 2023
Primary completionEst.
Sep 1, 2026
CompletionEst.
Dec 31, 2026
Last update
Jul 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05959161
Lead sponsor
Tianjin Huanhu Hospital
Responsible party
Guangrui Zhao (Associate Professor of Neurosurgery, Huanhu Hospital, Tianjin University, Tianjin Huanhu Hospital) — Principal investigator
First posted
Jul 25, 2023
Start date
Aug 1, 2023 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 25, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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