Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease
1 other identifier
interventional
47
1 country
1
Brief Summary
The intention of the study is to investigate whether Deep Brain Stimulation (DBS) will improve postural deformities of patients with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jul 2019
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2019
CompletedFirst Submitted
Initial submission to the registry
August 14, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedNovember 10, 2020
November 1, 2020
2.2 years
August 14, 2020
November 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sagittal Imbalance
Sagittal vertical axis (SVA) in X-Ray of the Spine. SVA is identified as the location of the head with respect to the normal center of gravity by a plumb line dropped from the center of the C7 vertebral body to the posterior superior corner of the sacral end plate. It is measured in cm with pathological values \>5cm and sagital Imbalance defined as SVA \>10cm.
Two years after DBS
Secondary Outcomes (11)
Spine Mobility
Two years after DBS
Oswestry Disability Index (ODI)
Two years after DBS
Visual Analoge Scale (VAS)
Two years after DBS
Unified Parkinsons Disease Rating Scala (Part III Motor Examination) (UPDRS-Part III)
Two years after DBS
Parkinsons Disease Questionaire 39 (PDQ-39)
Two years after DBS
- +6 more secondary outcomes
Study Arms (1)
DBS for Parkinsons Disease
EXPERIMENTALInterventions
Deep brain stimulation involves implanting electrodes within certain areas of the brain. These electrodes produce electrical impulses that regulate abnormal impulses. Or the electrical impulses can affect certain cells and chemicals within the brain. The amount of stimulation in deep brain stimulation is controlled by a pacemaker-like device placed under the skin in the upper chest. A wire that travels under the skin connects this device to the electrodes in the brain.
Eligibility Criteria
You may qualify if:
- women and men, over 18 years of age
- medical indication for deep brain Stimulation for Parkinson's Disease
- signed declaration of consent
You may not qualify if:
- withdrawal of consent
- non-Parkinson's-associated diseases of the spine
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité University Medicine Department of Neurosurgery Campus Charité Mitte
Berlin, 10117, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Spindler
Charite University, Berlin, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The Radiologist who evaluated X-rays ist masked regarding timepoint of investigation
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Philipp Spindler, Resident, Principal Investigator, Charite University medicine / department of neurosurgery
Study Record Dates
First Submitted
August 14, 2020
First Posted
August 24, 2020
Study Start
July 25, 2019
Primary Completion
September 30, 2021
Study Completion
September 30, 2023
Last Updated
November 10, 2020
Record last verified: 2020-11