Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2020

Interventions

  • Procedure: leg crossing
    • As Counter maneuvre legs will be crossed and cognitive tests will be performed.

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • blood pressure Change (mmHg)
    • Time Frame: during intervention (Leg crossing)
    • Change between blood pressure lying compared to compared to standing and leg crossing
  • Heart frequency Change (B/min)
    • Time Frame: during intervention (Leg crossing)
    • Change between heart frequency lying compared to compared to standing and leg crossing
  • cerebral blood flow velocity
    • Time Frame: during intervention (Leg crossing)
    • Change between cerebral blood flow compared to compared to standing and leg crossing

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrea Maier, Dr., Principal Investigator, Universitiy hospital RWTH Aachen, Department of Neurology
  • Overall Contact(s)
    • Andrea Maier, Dr., 0241 8085128, amaier@ukaachen.de

Citations Reporting on Results

Stewart JM, Del Pozzi AT, Pandey A, Messer ZR, Terilli C, Medow MS. Oscillatory cerebral blood flow is associated with impaired neurocognition and functional hyperemia in postural tachycardia syndrome during graded tilt. Hypertension. 2015 Mar;65(3):636-43. doi: 10.1161/HYPERTENSIONAHA.114.04576. Epub 2014 Dec 15.

Anderson JW, Lambert EA, Sari CI, Dawood T, Esler MD, Vaddadi G, Lambert GW. Cognitive function, health-related quality of life, and symptoms of depression and anxiety sensitivity are impaired in patients with the postural orthostatic tachycardia syndrome (POTS). Front Physiol. 2014 Jun 25;5:230. doi: 10.3389/fphys.2014.00230. eCollection 2014.

Arnold AC, Haman K, Garland EM, Raj V, Dupont WD, Biaggioni I, Robertson D, Raj SR. Cognitive dysfunction in postural tachycardia syndrome. Clin Sci (Lond). 2015 Jan;128(1):39-45. doi: 10.1042/CS20140251.

Gibbons CH, Centi J, Vernino S, Freeman R. Autoimmune autonomic ganglionopathy with reversible cognitive impairment. Arch Neurol. 2012 Apr;69(4):461-6. doi: 10.1001/archneurol.2011.2372. Epub 2011 Dec 12.

Guaraldi P, Poda R, Calandra-Buonaura G, Solieri L, Sambati L, Gallassi R, Cortelli P. Cognitive function in peripheral autonomic disorders. PLoS One. 2014 Jan 17;9(1):e85020. doi: 10.1371/journal.pone.0085020. eCollection 2014.

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