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Completed

NCT Number: NCT03681080

Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

People with POTS, autoimmune autonomic neuropathy (AAN), pure autonomic failure (PAF), SFN and Ehlers Danlos Syndrome (EDS) do not only suffer from orthostatic symptoms such as dizziness, headache, neck pain, blurred vision or (pre-) syncope. They also experience deficits in attention and concentration (more precisely deficits in selective perspective, operating speed, executive functions and memory performance) mainly in upright position. Only few studies concerning cognitive impairment in autonomic neuropathies, their frequency, aetiology and therapy exist. Many patients concerned, especially with POTS, report attention deficits and "brain fog" with problems in their everyday life and work, predominantly in upright posture. Specific symptomatic or medical therapies do not exist. Medical treatment with Modafinil is discussed and part of a current study at Vanderbilt Autonomic Dysfunction Centre (1-5). The investigators want to investigate if problems of concentration, attention and/or cognitive dysfunction exist in people with POTS, AAN, SFN and EDS compared to healthy controls (HC). Thus the investigators use detailed clinical, autonomic and neuropsychological tests in different body positions (lying, sitting and standing) as also acute therapy (leg crossing).

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Key information

Conditions

Autonomic Failure Autonomic Nervous System Diseases Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dysautonomia Ehlers-Danlos Syndrome Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders Orthostatic Intolerance Postural Orthostatic Tachycardia Syndrome Postural Tachycardia Syndrome Primary Dysautonomias Pure Autonomic Failure Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

We are still recruting healthy controls and patients with autoimmune autonomic neuropathy in order to perform titl table examination and laboratory testing on day one, ono an empty stomach, without morning medication. Cognitive testing is performed on day two after randomization in three groups: lying, standing and standing with legs crossed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AAN, SFN, hEDS, POTS or healthy control
  • diagnosis in our clinic on the basis of anamnesis, clinical data as neurological examination, tilt table, QST, skin biopsy, norepinephrine values, vitamine B12, antibodies

Exclusion criteria

for all participants

  • pregnancy, nonage,severe heart insufficiency, deep brain Stimulation, pace maker, drug consumption, large fibre polyneuropathy for controls
  • medication influencing blood pressure, psychiatric disease, synkopes or dizziness, neurological disorders esp. polyneuropathy, dementia, vitamine or iron deficiency

Treatment and study plan

leg crossing

Procedure

As Counter maneuvre legs will be crossed and cognitive tests will be performed.

Primary outcomes

  1. cognitive function: Stroop, TMT A und B

    Time frame: during intervention (Leg crossing)

    Change of results of cognitive function tests lying compared to standing and leg crossing

Secondary outcomes

  1. blood pressure Change (mmHg)

    Time frame: during intervention (Leg crossing)

    Change between blood pressure lying compared to compared to standing and leg crossing

  2. Heart frequency Change (B/min)

    Time frame: during intervention (Leg crossing)

    Change between heart frequency lying compared to compared to standing and leg crossing

  3. cerebral blood flow velocity

    Time frame: during intervention (Leg crossing)

    Change between cerebral blood flow compared to compared to standing and leg crossing

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Understanding Impaired Concentration, Attentional Deficits and Their Pathophysiology in Postural Orthostatic Tachycardia Syndrome (POTS) and Other Autonomic Neuropathies (POTSKog-Study Aachen)

Acronym: POTSKog

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Sep 21, 2018
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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