Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

Cognitive Impairment Clinical Trial

— POTSKog  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681080
• Other study ID #: 17-006
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Autonomic Failure
• Autonomic Nervous System Diseases
• Cognitive Impairment
• Dysautonomia
• Ehlers-Danlos Syndrome
• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Primary Dysautonomias
• Pure Autonomic Failure
• Syndrome
• Tachycardia

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)