Clinical trial NCT04524377: Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease
Official title: Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Spine Degeneration
Spine Deformity
Spinal Disease
Keywords: Deep Brain Stimulation
Parkinson Disease
Spine
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Deep Brain Stimulation (DBS) of the Nucelus subthalamicus (STN) in patients with Parkinson's Disease (PD).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* women and men, over 18 years of age
* medical indication for deep brain Stimulation for Parkinson's Disease
* signed declaration of consent

Exclusion Criteria:

* withdrawal of consent
* non-Parkinson's-associated diseases of the spine
* pregnancy

Primary outcomes:
measure: Sagittal Imbalance
timeFrame: Two years after DBS
Secondary outcomes:
measure: Spine Mobility
timeFrame: Two years after DBS
measure: Oswestry Disability Index (ODI)
timeFrame: Two years after DBS
measure: Visual Analoge Scale (VAS)
timeFrame: Two years after DBS
measure: Unified Parkinsons Disease Rating Scala (Part III Motor Examination) (UPDRS-Part III)
timeFrame: Two years after DBS
measure: Parkinsons Disease Questionaire 39 (PDQ-39)
timeFrame: Two years after DBS
measure: Pelvic incidence (PI)
timeFrame: Two years after DBS
measure: Pelvit tilt (PT)
timeFrame: Two years after DBS
measure: Sacral slope (SS)
timeFrame: Two years after DBS
measure: Lumbar Lordisis (LL)
timeFrame: Two years after DBS
measure: Mismatch of Pelvic incidence and LL (PI - LL)
timeFrame: Two years after DBS
measure: Scoliosis
timeFrame: Two years after DBS
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine Department of Neurosurgery Campus Charité Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Philipp Spindler
role: PRINCIPAL_INVESTIGATOR
References: