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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006735 |
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Date of registration:
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08/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Registry for Apomorphine-, L-Dopa-Infusiontherapy and Deep Brain Stimulation in Patients with Parkinson’s Disease
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Scientific title:
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Registry for Apomorphine-, L-Dopa-Infusiontherapy and Deep Brain Stimulation in Patients with Parkinson’s Disease - Real-DBS-PD |
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Date of first enrolment:
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15/07/2012 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00006735 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Germany
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United Kingdom
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Contacts
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Name:
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Lars
Timmermann |
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Address:
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Kerpenerstr. 62
50937
Cologne
Germany |
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Telephone:
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0049 221 478 7494 |
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Email:
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lars.timmermann at uk-koeln.de |
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Affiliation:
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Department of NeurologyUniversity Hospital Cologne |
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Name:
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Lars
Timmermann |
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Address:
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Kerpenerstr. 62
50937
Cologne
Germany |
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Telephone:
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0049 221 478 7494 |
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Email:
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lars.timmermann at uk-koeln.de |
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Affiliation:
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Department of NeurologyUniversity Hospital Cologne |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with PD, diagnosed according to British Brain Bank criteria which are eligible for treatment with Apomorphine and intra-jejunal l-dopa infusion therapy and deep brain stimulation.
Exclusion criteria: - Clinically significant irregularities in the MRI scan like, e.g., strokes, cerebellar atrophy, and tumors.
- Clinically significant psychiatric diseases.
- Clinicallly significant neuropsychological impairments.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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G20.00
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G20.00
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Intervention(s)
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Group 1: Deep brain stimulation: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
Group 2: Intra-jejunal levodopa infusion therapy: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
Group 3: Subcutaneous Apomorphine infusion therapy: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
Group 4: Conventional pharmaco-therapy: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
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Primary Outcome(s)
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Non-motor (Non-motor Symptom Scale) and quality of life (Parkinson's Disease Questionnaire)
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Secondary Outcome(s)
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Demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms
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Source(s) of Monetary Support
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Department of NeurologyUniversity Hospital Cologne
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Ethics review
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Status: Approved
Approval date: 10/07/2012
Contact:
gs-ek@uni-koeln.de
Ethikkommission der Medizinischen Fakultät der Universität zu Köln
+49-221-478 82900
gs-ek@uni-koeln.de
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