Vagus Somatosensory Evoked Potentials and Near-infrared Spectroscopy in the Early Diagnosis of Dementia (Vogel)
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|ClinicalTrials.gov Identifier: NCT02224326|
Recruitment Status : Active, not recruiting
First Posted : August 25, 2014
Last Update Posted : May 20, 2022
In its long preclinical course, AD shows a spreading pattern of specific pathology in a uniform sequence of predictable steps including brainstem nuclei in early stages. Many of these nuclei which are early involved in AD take equally part in the afferences of the Xth cranial nerve, the Vagus nerve. A method for the functional assessment of Vagus-related nuclei in the lower brainstem is the technique of somatosensory evoked potentials of the Vagus nerve (VSEP). This method targets the accessibility of early functional changes by evoked potentials on one hand and the early affection of specific brainstem nuclei comprising Vagus afferences in the course of AD on the other hand. The method of VSEP takes advantage of the transcutaneous stimulation of the auricular branch of the Vagus nerve (ABVN) which is presumed to be the only sensory part of this nerve innervating parts of the outer meatus acoustics at the tragus. This cutaneous branch was shown to gain access to Vagus afferences via brainstem regions which are affected in the course of AD. VSEP latencies in AD were shown to be significantly longer as compared to healthy controls. Yet, if VSEP really are suited for the early detection of AD is still not known.
Functional near-infrared spectroscopy (fNIRS) measures changes in cerebral oxygenation by means of near-infrared light using wavelengths of 650-850 nm. The principle of fNIRS is based on the principle that regional neuronal activation of the brain leads to an increase in metabolism and oxygenation of brain tissue in that region which is accompanied by an elevated regional cerebral blood flow. In AD, there is a growing body of literature reporting deviant fNIRS activation patterns for a variety of tasks. For example, it was shown that the fNIRS activation pattern in frontal and parietal cortex areas in subjects with AD performing the line orientation paradigm is clearly different from healthy controls. Yet, if fNIRS is suited as a means of early detection of AD is not known.
Therefore we aimed at testing the predictive value of VSEP and fNIRS in the early detection of AD. The hypothesis to be tested within this study states that subjects developing AD or MCI within an observation period of 6 years depict longer VSEP latencies, a different fNIRS oxygenation pattern and a lower performance in neuropsychologic rating below the level of dementia at baseline than those who remain cognitively stable.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||604 participants|
|Official Title:||Prospective Study to Evaluate the Predictive Value of Vagus Somatosensory Evoked Potentials (VSEP) and Near-infrared Spectroscopy (NIRS) in the Early Diagnosis of Alzheimer´s Disease|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
- Mini Mental State Examination (MMSE) [ Time Frame: 6 years ]
- Dementia detection test [ Time Frame: 6 years ]
- Activities of daily living scale [ Time Frame: 6 years ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224326
|University Clinic Wuerzburg|
|Wuerzburg, Germany, D-97080|
|Principal Investigator:||Jürgen Deckert, MD||University Clinic Wuerzburg, Dept. of Psychiatry, Psychosomatics and Psychotherapy, Fuechsleinstrasse 15, D-97080 Wuerzburg, Germany|
|Study Director:||Thomas Polak, MD||University Clinic Wuerzburg, Dept. of Psychiatry, Psychosomatics and Psychotherapy, Fuechsleinstrasse 15, D-97080 Wuerzburg, Germany|
|Study Director:||Martin J Herrmann, PhD||University Clinic Wuerzburg, Dept. of Psychiatry, Psychosomatics and Psychotherapy, Fuechsleinstrasse 15, D-97080 Wuerzburg, Germany|
|Study Director:||Martin Lauer, MD|