Parkinson DiseaseNCT04524377
Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease
A study testing Deep Brain Stimulation in people with Parkinson Disease and Spine Degeneration, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The intention of the study is to investigate whether Deep Brain Stimulation (DBS) will improve postural deformities of patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Spine Degeneration, Spine Deformity
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men, over 18 years of age
- medical indication for deep brain Stimulation for Parkinson's Disease
- signed declaration of consent
Who cannot join
- withdrawal of consent
- non-Parkinson's-associated diseases of the spine
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité University Medicine Department of Neurosurgery Campus Charité Mitte
Berlin, 10117
Philipp Spindler, +49(0)30450660778, philipp.spindler@charite.de
About this study
The intention of the study is to investigate whether Deep Brain Stimulation (DBS) will improve postural deformities of patients with Parkinson's disease.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Parkinson Disease, Spine
- Medical subject headings
- Parkinson Disease, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DBS for Parkinsons Disease | Experimental | Not described Receives: Procedure: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years after DBS
Secondary outcomes (11)
Spine Mobility
Function of the back as well as the position and movement of the pelvis in patients with Parkinson's disease with a non-invasive measuring system, (Epionics SPINE System®). Scope (in degrees) and speed (in degrees/s) of motion are measured.
Measured: Two years after DBS
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered summed up and multiplied by two. To obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: Two years after DBS
Visual Analoge Scale (VAS)
VAS measure of subjective or behavioral experience of back pain. Range 0-10 with higher scores indicating more severe symptoms.
visual analog scale
Measured: Two years after DBS
Unified Parkinsons Disease Rating Scala (Part III Motor Examination) (UPDRS-Part III)
The unified Parkinson's disease rating scale (UPDRS) to follow the longitudinal course of Parkinson's disease. Part III deals with motor experiences of daily living. It consists of 18 items. Each item has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe
Measured: Two years after DBS
Parkinsons Disease Questionaire 39 (PDQ-39)
The PDQ-39 is a PD specific health status questionnaire comprising 39 items. Participants are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100% more health problems).
Measured: Two years after DBS
Pelvic incidence (PI)
The pelvic incidence (PI) corresponds to the angle between the perpendicular to the upper S1 level passing through its center and the line connecting this point to the axis of the femoral heads. Normal 45 ° to 65 °
Measured: Two years after DBS
Pelvit tilt (PT)
The pelvic tilt (PT) is defined by the angle between the vertical and the line connecting the center of the sacral endplate to the axis of the femoral heads. Normal 3° to 18°
Measured: Two years after DBS
Sacral slope (SS)
The sacral slope (SS) is defined by the angle between a line tangent to the upper S1 endplate and horizontal line. Normal -32° to -49°
Measured: Two years after DBS
Lumbar Lordisis (LL)
Lumbar lordosis angle measures between the superior endplate of L1 and L5 inferior endplate. Norm 33.2 +/- 12.1 degrees
Measured: Two years after DBS
Mismatch of Pelvic incidence and LL (PI - LL)
Difference between pelvic incidence and lumbar lordisis. Norm <10 degrees
Measured: Two years after DBS
Scoliosis
Cobb Angle at a particular region of the vertebral column, when measured from the superior endplate of a superior vertebra to the inferior endplate of an inferior vertebra. No scoliosis <10°, mild scoliosis 10-30°, moderate scoliosis 30-45°, severe scoliosis >45°
Measured: Two years after DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start25 Jul 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Deep Brain Stimulation (DBS) of the Nucelus subthalamicus (STN) in patients with Parkinson's Disease (PD).
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Spindler, Charite University, Berlin, Germany
- Investigators
- Philipp Spindler, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524377
- Sponsor's protocol ID
- 40000256
- Status last verified
- Nov 2020
- First submitted
- 14 Aug 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04524377
- Acronym / sponsor ID
- 40000256
- Conditions
- Parkinson Disease, Spine Degeneration, Spine Deformity, Spinal Disease
- Keywords
- Deep Brain Stimulation, Parkinson Disease, Spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Deep Brain Stimulation (DBS) of the Nucelus subthalamicus (STN) in patients with Parkinson's Disease (PD).
| Arm | Type | Receives |
|---|---|---|
| DBS for Parkinsons Disease | Experimental | Procedure: Deep Brain Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women and men, over 18 years of age
- medical indication for deep brain Stimulation for Parkinson's Disease
- signed declaration of consent
Key exclusion criteria (3 listed)
- withdrawal of consent
- non-Parkinson's-associated diseases of the spine
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationDeep 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. | Procedure or surgery | DBS for Parkinsons Disease |
Primary outcome
Sagittal Imbalance
Time frame: Two years after DBS
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.
11 secondary outcomes
Spine Mobility
Time frame: Two years after DBS
Oswestry Disability Index (ODI)
Time frame: Two years after DBS
Visual Analoge Scale (VAS)
Time frame: Two years after DBS
Unified Parkinsons Disease Rating Scala (Part III Motor Examination) (UPDRS-Part III)
Time frame: Two years after DBS
Parkinsons Disease Questionaire 39 (PDQ-39)
Time frame: Two years after DBS
Pelvic incidence (PI)
Time frame: Two years after DBS
Pelvit tilt (PT)
Time frame: Two years after DBS
Sacral slope (SS)
Time frame: Two years after DBS
Lumbar Lordisis (LL)
Time frame: Two years after DBS
Mismatch of Pelvic incidence and LL (PI - LL)
Time frame: Two years after DBS
Scoliosis
Time frame: Two years after DBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Spindler principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson Disease and Spine Degeneration, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Spindler (+49(0)30450660778, philipp.spindler@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sagittal Imbalance (time frame: Two years after DBS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.