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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: |
DRKS00012931 |
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Date of registration:
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08/09/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hypogeusia In Vim/DRT-DBS
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Scientific title:
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Hypogeusia In Vim/DRT-DBS - HIDDen |
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Date of first enrolment:
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18/10/2017 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting stopped after recruiting started |
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URL:
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http://drks.de/search/en/trial/DRKS00012931 |
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Study type:
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interventional |
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Study design:
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Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: diagnostic
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Bastian
Sajonz |
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Address:
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Breisacher Str. 64
79104
Freiburg
Germany |
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Telephone:
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+49 761 270 50010 |
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Email:
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bastian.sajonz@uniklinik-freiburg.de |
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Affiliation:
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Universitätsklinikum FreibugKlinik für NeurochirurgieAbteilung für Funktionelle und Stereotaktische Neurochirurgie |
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Name:
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Bastian
Sajonz |
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Address:
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Breisacher Str. 64
79104
Freiburg
Germany |
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Telephone:
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+49 761 270 50010 |
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Email:
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bastian.sajonz@uniklinik-freiburg.de |
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Affiliation:
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Universitätsklinikum FreibugKlinik für NeurochirurgieAbteilung für Stereotaktische und Funktionelle Neurochirurgie |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Adult tremor patients who are being treated with DBS and where DTI imaging data is available. Decision for DBS therapy is made according to standard guidelines outside this study.
2. Written informed consent.
Exclusion criteria: 1. Patients suffering from multiple sclerosis.
2- Patients with allergies on citric acid or chinine.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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G25.0
R43.8
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Essential tremor
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R43.8
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Other and unspecified disturbances of smell and taste
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G25.0
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Intervention(s)
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Group 1: Pre-operative gustometry, olfactometry and rhinomanometry prior to implantation of DBS (Deep Brain Stimulation) system. Post-operative gustometry, olfactometry and rhinomanometry 6-12 months after implantation. When post-operative results differ from pre-operative test results gustometry, olfactometry and rhinomanometry will be repeated with DBS stimulator turned OFF.
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Primary Outcome(s)
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To compare gustatory and olfactory function by means of olfactometry and gustometry preoperatively as well as 6-12 months after Implantation of DBS (Deep Brain Stimulation)
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Secondary Outcome(s)
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Identification of risk factors for stimulation-induced hypogeusia (age, sex, pre-existing disturbance of olfaction or gustation).
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Source(s) of Monetary Support
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Universitätsklinikum FreibugKlinik für NeurochirurgieAbteilung für Funktionelle und Stereotaktische Neurochirurgie
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Ethics review
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Status: Approved
Approval date: 11/08/2017
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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