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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681080
Other study ID # 17-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date May 30, 2023

Study information

Verified date June 2023
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 30, 2023
Est. primary completion date May 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany University Hospital, RWTH Aachen Aachen Nordrhein Westfalen

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Maier A, Schopen L, Thiel JC, Muller K, Fimm B, Schulz JB. Cognitive functioning in postural orthostatic tachycardia syndrome among different body positions: a prospective pilot study (POTSKog study). Clin Auton Res. 2023 Jun 1. doi: 10.1007/s10286-023-00 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary cognitive function: Stroop, TMT A und B Change of results of cognitive function tests lying compared to standing and leg crossing during intervention (Leg crossing)
Secondary blood pressure Change (mmHg) Change between blood pressure lying compared to compared to standing and leg crossing during intervention (Leg crossing)
Secondary Heart frequency Change (B/min) Change between heart frequency lying compared to compared to standing and leg crossing during intervention (Leg crossing)
Secondary cerebral blood flow velocity Change between cerebral blood flow compared to compared to standing and leg crossing during intervention (Leg crossing)
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