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Tiskalniku prijaznoNew tools for the assessment of social stress and stress related disorders in humans (Ref: 10 DE 1169 3GF7)
Technology Offer
 
A small German company performing phase I and IV clinical trials for pharmaceutical companies, clinical studies for healthcare and food supplements industry developed new tools for the assessment of stress and stress-related disorders in humans. The tools produce high reproducible data about the impact of psychotropic compounds or allow to personalising individual treatments. The company seeks industrial and academic partnerships for commercial agreements and further research and development.
 
The core competence of the German research contract company lies in the development of diagnostic systems based on neurobiological research for social stress in humans. Performing phase I and IV clinical trials for pharmaceutical companies and clinical studies for healthcare and food supplements industries the company has developed a new pharmacodynamic test that serves as a tool for assessing the impact of psychotropic compounds on anxiety, depressions and stress in humans. Based on many years of development and experience the company provides the highest standard and expertise in applying this protocol in clinical research.

1) The Trier Social Stress Test (TSST)
As the first Clinical Research Organisation (CRO) they demonstrated the high sensitivity of the "Trier Social Stress Test" to the effects of anxiolytic compounds. It has been shown that psychobiological reaction profiles can be influenced by nutraceuticals, functional food or psychotropic drugs. The test is based on the changing of these reaction patterns in response to consumed compounds or applied therapeutics.
Depending on the compound and the target, different measuring instruments are available to be added to the study protocol that is performed in nine different Modules:

Module I  Autonomic Response Measures
+ blood pressure, epinephrine, norepinephrine
+ electrocardiogram, heart rate variability
+ electrodermal activity, perspiration
+ body temperature
+ pupilography

Module II - Endocrinological Response Measures
+ ACTH, serum and salivary cortisol
+ prolactin, growth hormone, DHEA

Module III  Immunological Response Measures
+ leukocyte subsets
+ cytokines

Module IV  Hematological Response Measures
+ hematocrit , hemoglobin

Module V  Metabolic Response Measures
+ methabolic measures

Module VI  Gene Expression
+ repression, induction profiles of genes in target tissues

Module VII  Psychomotor Response Measures
+ electromyogram
+ voice (spectral analyses)
+ limb movements
+ dexterity

Module VIII  Psychological Response Measures
+ state anxiety
+ mood, anger, fear, helplessness
+ coping
+ memory, attention

Module IX  Pain threshold

Although the TSST is today considered the "gold standard" in human stress research, the protocol is rather rigid. Thus, they introduce an extended modulary protocol, the "tsst+", which allows to specifically adapt this test to given research demands.

The different standardised modules now allow to separately assess treatment effects on the following variables:

(a) Psychological stress by self-assessment and panel-assessment at relevant
time points;
(b) psychomotor responses by voice analyses and limb movements;
(c) autonomic responses by skin conductance, heart rate, blood pressure, and
levels of epinephrine and norepinephrine;
(d) endocrine and metabolic responses;
(e) immune responses;
(f) oxidative stress responses
(g) pain sensitivity


2) The NeuropatternTM:
Chronic stress can provoke numerous dysfunctions of brain and the body. A new diagnostic system based on the most recent neurobiological research has been developed to improve treatment of stress related health disorders. This psychobiological diagnostic tool can easily be applied in in- and outpatients screening for discrete endophenotypes, related to stress related disorders, such as anxiety, depression, somatoform and adjustment disorders. The tool serves to discriminate subgroups of patients, and allows personalized treatments.

Functioning of the NeuropatternTM:
The diagnostic tool consists of a small portable cardiogram, questionnaires and small storage vessels for collecting saliva. The medical practitioner attaches the ECG and fills in a medical questionnaire, the patient collects samples at home or in his professional surroundings. Everything is sent to the company for analysing. The results provide conclusions on the patients individual disease pattern and allows recommendations with reference to specific psycho-and pharmaco-therapeutic treatments.

Innovative Aspects:
" The TSST has shown to reliably provoke stress and social anxiety under
laboratory conditions, accompanied by a robust autonomic and endocrine
response. The TSST has further proven a useful paradigm for the detection of
anxiolytic properties of drugs.
" The development of a modification of the TSST allows to specifically adapt
this test to given research demands.
" The NeuropatternTM can be used within the examination of a general
practitioner in order to explore a neurobiological disease pattern under the
patients normal environment.
" This assessment allows information on a neurobiological profile and leads to
a personalized behavioral and medical recommendation for the general
practitioner. (see: Hellhammer&Hellhammmer (Ed.: Stress  The Brain-Body
Connection. Karger, 2008)
 
Entry date:09.02.2010
Deadline:05.02.2011
 
Organisation country:Germany
Development stage:Already on the market
Intellectual property:Copyright(s) registered
Collaboration type:Joint further development;Testing of new applications;Adaptation to specific needs;Technical consultancy
Collaboration type comments:- Type of partner sought:
Healthcare, pharmaceutical, food and cosmetic industry and clinical/medical research organisations, public and private research organisations.

- Specific area of activity of the partner:
Partners should be active in pharmaceutical research and development, development of food supplements and functional food.
Academic partners interested in behaviour research or social science.

- Task to be performed by the partner sought:
The client or partner provides compounds, drugs or industrial products from which data about the psychotropic or anxiolytic properties should be collected.
The partner carries out case studies in single patients, larger epidemiologic or clinical studies and needs additional data about the stress relation of health disorders or the neurobiological pattern of patients or test persons.
 
Nadaljnja navodila
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Tvoja Evropa

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Competitiveness and Innovation framework programme 2007-2013
European Commission - Enterprise and Industry
Institut "Jožef Stefan"
Univerza v Mariboru, Center za interdisciplinarne in multidisciplinarne raziskave in študije
Gospodarska zbornica Slovenije
Obrtno-podjetniška zbornica Slovenije
Mariborska razvojna agencija
Univerza na Primorskem
Znanstveno-raziskovalno središče Koper