Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS)
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ClinicalTrials.gov Identifier: NCT04707638 |
Recruitment Status :
Withdrawn
(Ethics application has not been completed yet)
First Posted : January 13, 2021
Last Update Posted : February 3, 2021
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Condition or disease | Intervention/treatment |
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Parkinson Disease Dystonia | Other: No intervention used |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 1 Year |
Official Title: | Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS) Under General Anesthesia for Patients With Parkinson's Disease or Dystonia and Their Correlation With Prognosis |
Actual Study Start Date : | January 1, 2021 |
Estimated Primary Completion Date : | January 11, 2023 |
Estimated Study Completion Date : | January 11, 2023 |

Group/Cohort | Intervention/treatment |
---|---|
Parkinson's disease or dystonia patients
Patients with Parkinson's disease or dystonia and underwent STN DBS under general anesthesia in neurosurgery department
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Other: No intervention used
No intervention used |
- Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Two years postoperatively ]UPDRS has four parts: part I (nonmotor experiences of daily living, total score=16); part II (patient motor experience of daily living, total score=52); part III (clinician motor examination, total score=56); part IV (complications, total score=23). The total score of all the four parts is147. Higher scores means a worse outcome.
- Burke Fahn Marsden's Dystonia Rating Scales(BFMDRS) [ Time Frame: Two years postoperatively ]BFMDRS has two parts: BFMDRS movement part (BFMDRS-M) and BFMDRS disability part (BFMDRS-D). The total score of BFMDRS-M is 120 and the total score of BFMDRS-D is 30. Higher scores means a worse outcome.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients underwentSTN-DBS in neurosurgery department of Wuhan Union Hospital.
- Patients with Parkinson's disease or dystonia.
Exclusion Criteria:
1.Patients without enough follow-up length.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707638
Principal Investigator: | Fu Peng, PHD | Neurosurgery department of Wuhan Union Hospital |
Responsible Party: | Wuhan Union Hospital, China |
ClinicalTrials.gov Identifier: | NCT04707638 |
Other Study ID Numbers: |
NS20201230 |
First Posted: | January 13, 2021 Key Record Dates |
Last Update Posted: | February 3, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Dystonia deep brain stimultation neurophysiological characteristics |
Parkinson Disease Dystonia Dystonic Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Dyskinesias Neurologic Manifestations |