NCT04524377

Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intention of the study is to investigate whether Deep Brain Stimulation (DBS) will improve postural deformities of patients with Parkinson's disease.

Detailed description

1. Introduction 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

• Parkinson Disease
• Spine Degeneration
• Spine Deformity
• Spinal Disease

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2019-07-25
• Primary completion: 2021-09-30
• Completion: 2023-09-30
• First posted: 2020-08-24
• Last updated: 2020-11-10

Locations

1 site across 1 country: Germany