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

NCT02224326 | Completed

• 1 other identifier: Vogel-1
• Study Type: observational
• Target: 604
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer´s Disease

Keywords

Alzheimer´s disease; early diagnosis; evoked potentials; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Mini Mental State Examination (MMSE)

  6 years

Secondary Outcomes (1)

• Dementia detection test

  6 years

Other Outcomes (1)

• Activities of daily living scale

  6 years

Eligibility Criteria

• Age: 70 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wuerzburg: lead

Study Sites (1)

University Clinic Wuerzburg

Würzburg, D-97080, Germany

Location

Related Publications (4)

• Katzorke A, Zeller JBM, Muller LD, Lauer M, Polak T, Deckert J, Herrmann MJ. Decreased hemodynamic response in inferior frontotemporal regions in elderly with mild cognitive impairment. Psychiatry Res Neuroimaging. 2018 Apr 30;274:11-18. doi: 10.1016/j.pscychresns.2018.02.003. Epub 2018 Feb 11.

  PMID: 29472145 BACKGROUND

• Zeller JBM, Katzorke A, Muller LD, Breunig J, Haeussinger FB, Deckert J, Warrings B, Lauer M, Polak T, Herrmann MJ. Reduced spontaneous low frequency oscillations as measured with functional near-infrared spectroscopy in mild cognitive impairment. Brain Imaging Behav. 2019 Feb;13(1):283-292. doi: 10.1007/s11682-018-9827-y.

  PMID: 29362991 BACKGROUND

• Polak T, Herrmann MJ, Muller LD, Zeller JBM, Katzorke A, Fischer M, Spielmann F, Weinmann E, Hommers L, Lauer M, Fallgatter AJ, Deckert J. Near-infrared spectroscopy (NIRS) and vagus somatosensory evoked potentials (VSEP) in the early diagnosis of Alzheimer's disease: rationale, design, methods, and first baseline data of the Vogel study. J Neural Transm (Vienna). 2017 Nov;124(11):1473-1488. doi: 10.1007/s00702-017-1781-0. Epub 2017 Sep 1.

  PMID: 28864837 BACKGROUND

• Herrmann MJ, Wuttke A, Breuninger L, Eff J, Ettlinger S, Fischer M, Gotzelmann A, Gram A, Pomper LD, Schneider E, Schwitalla L, Siminski N, Spielmann F, Weinmann E, Weyel V, Zeller JBM, Lauer M, Deckert J, Polak T. Functional near-infrared spectroscopy and vagus somatosensory evoked potentials add to the power of established parameters such as poor cognitive performance, dsyosmia and APOe genotype to predict cognitive decline over 8 years in the elderly. J Neural Transm (Vienna). 2025 Mar;132(3):455-468. doi: 10.1007/s00702-024-02859-y. Epub 2024 Nov 13.

  PMID: 39535568 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jürgen Deckert, MD

  University Clinic Wuerzburg, Dept. of Psychiatry, Psychosomatics and Psychotherapy, Fuechsleinstrasse 15, D-97080 Wuerzburg, Germany

  PRINCIPAL INVESTIGATOR

• Thomas Polak, MD

  University Clinic Wuerzburg and Hephata Diakonie, Hauptstraße 280, D-63879 Weibersbrunn, 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: September 7, 2013
• First Posted: August 25, 2014
• Study Start: June 1, 2011
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

DE (1)