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Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies (POTSKog)

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ClinicalTrials.gov Identifier: NCT03681080
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Autonomic Failure Dysautonomia Cognitive Impairment Ehlers-Danlos Syndrome Postural Tachycardia Syndrome Pure Autonomic Failure Procedure: leg crossing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Understanding Impaired Concentration, Attentional Deficits and Their Pathophysiology in Postural Orthostatic Tachycardia Syndrome (POTS) and Other Autonomic Neuropathies (POTSKog-Study Aachen)
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021


Arm Intervention/treatment
No Intervention: lying
cognitive tests are performed during lying in all groups (SFN, AAN, EDS, POTS and controls)
No Intervention: standing
cognitive tests are performed during active Standing in all groups (SFN, AAN, EDS, POTS and controls)
Experimental: crossed legs
cognitive tests are performed during leg crossing in all groups (SFN, AAN, EDS, POTS and controls)
Procedure: leg crossing
As Counter maneuvre legs will be crossed and cognitive tests will be performed.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03681080


Contacts
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Contact: Andrea Maier, Dr. 0241 8085128 amaier@ukaachen.de
Contact: Joana Schauermann 0241 8085128 jschauermann@ukaachen.de

Locations
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Germany
University Hospital, RWTH Aachen Recruiting
Aachen, Nordrhein Westfalen, Germany, 52074
Contact: Andrea Maier, Dr.    +49 241 8085128    amaier@ukaachen.de   
Contact: Joana Schauermann    +49 241 8085128    jschauermann@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Andrea Maier, Dr. Universitiy hospital RWTH Aachen, Department of Neurology

Publications of Results:
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03681080     History of Changes
Other Study ID Numbers: 17-006
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Ehlers-Danlos Syndrome
Syndrome
Pure Autonomic Failure
Primary Dysautonomias
Tachycardia
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Autonomic Nervous System Diseases
Nervous System Diseases
Orthostatic Intolerance
Hemostatic Disorders
Vascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases