Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease
NCT ID: NCT04524377
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
47 participants
INTERVENTIONAL
2019-07-25
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Postural deformities are frequent comorbidities that limit the quality of life in patients with Parkinson's disease. Subject of the study is the investigation of postural deformities as a concomitant disease in connection with therapy with DBS. The aim of this prospective study is to examine the effect of deep brain stimulation on postural instability and thus the quality of life of patients.
2. Study outline
The aim of this prospective study is to investigate the effect of DBS on postural instability and thus the quality of life of patients.
For this purpose, the investigators would like to evaluate 50 participants before and at certain time points (three, six, twelve and 24 months) after DBS surgery. X-rays of the entire spine are carried out using EOS® technology and biodynamic measurements of the spine using the Epionics SPINE ® system. In addition, the Investigators collect the 39-item PD Questionnaires (PDQ-39), Unified Parkinson's Disease Rating Scale (UPDRS) Part III, Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) as clinical parameters.
Our hypotheses (I): DBS improves the sagittal balance of the spine and the pelvic rotation as a corresponding compensation mechanism for this incorrect posture (II) The participant's mobility improves in course of DBS in terms of scope and speed (III) In course after DBS, back pain is significantly reduced and the participant's everyday life is easier to cope with.
The investigators hope to gain new insights into the pathophysiology of the spinal deformities associated with Parkinson's disease from the study and to expand the indication for DBS to include clinically relevant spinal complaints.
3. Consent to the study
The study was positively assessed by the Charité ethics committee and the Federal Office for Radiation Protection.
Consent for study inclusion is sought after explanation and agreement to DBS treatment for participants with Parkinson's disease. Thus, participants capable of consenting to the DBS treatment get the study details explained themselves and may or may not agree to participate. If a participant is incapable for consenting to the proposed treatment, he may not be enrolled in the study.
4. Safety of DBS for Parkinson's disease and further risks for participants
Deep brain stimulation is a well-established and well-tolerated treatment for Parkinson's disease.
The study-related risks result from the multiple X-ray examinations of the spine (effective dose 2.6 µSv per examination). There are no other study-related risks of the planned ones.
5. Insurance Coverage
An insurance was taken out for all study participants who took part in this study at HDI-Gerling Industrie Versichung AG, Riethorst 2, 30659 Hanover, Insurance number: 5701032603017.
German laws §§ 40 to 42 Arzneimittelgesetz or §§ 20 to 23 Medizinproduktegesetz are not applicable.
The Investigators are insured against fault-based damage through the existing liability insurance of their clinic.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DBS for Parkinsons Disease
Deep Brain Stimulation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deep Brain Stimulation
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* medical indication for deep brain Stimulation for Parkinson's Disease
* signed declaration of consent
Exclusion Criteria
* non-Parkinson's-associated diseases of the spine
* pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Charite University, Berlin, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Philipp Spindler
Dr. med. Philipp Spindler, Resident, Principal Investigator, Charite University medicine / department of neurosurgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philipp Spindler
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Charité University Medicine Department of Neurosurgery Campus Charité Mitte
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Philipp Spindler
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
40000256
Identifier Type: -
Identifier Source: org_study_id