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Vagus Somatosensory Evoked Potentials and Near-infrared Spectroscopy in the Early Diagnosis of Dementia (Vogel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02224326
Recruitment Status : Active, not recruiting
First Posted : August 25, 2014
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Thomas Polak, University of Wuerzburg

Brief Summary:

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
Alzheimer´s Disease

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Study Type : Observational
Actual Enrollment : 604 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mini Mental State Examination (MMSE) [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. Dementia detection test [ Time Frame: 6 years ]

Other Outcome Measures:
  1. Activities of daily living scale [ Time Frame: 6 years ]

Biospecimen Retention:   Samples With DNA
whole blood, serum


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Ages Eligible for Study:   70 Years to 78 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Inhabitants of Wuerzburg, the 130 000 inhabitants capital of the german district Lower Franconia who are born between 1.4.1936 and 31.3.1941
Criteria

Inclusion Criteria:

  • inhabitant of Wuerzburg
  • born between 1.4.1936 and 31.3.1941
  • able to give informed consent

Exclusion Criteria:

  • manifestation of - apart from dementia - other severe psychiatric disease such as Schizophrenia, neurologic disease such as Parkinson´s disease or stroke or intern disease such as cancer within the past 12 months
  • severe, uncorrected see or hearing disturbance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224326


Locations
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Germany
University Clinic Wuerzburg
Wuerzburg, Germany, D-97080
Sponsors and Collaborators
University of Wuerzburg
Investigators
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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 University Clinic Wuerzburg, Dept. of Psychiatry, Psychosomatics and Psychotherapy, Fuechsleinstrasse 15, D-97080 Wuerzburg, Germany
Publications:
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Responsible Party: Thomas Polak, Senior Physician, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT02224326    
Other Study ID Numbers: Vogel-1
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Keywords provided by Thomas Polak, University of Wuerzburg:
Alzheimer´s disease
early diagnosis
evoked potentials
near-infrared spectroscopy
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders