Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

NCT03681080 | Completed

• 1 other identifier: 17-006
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Autonomic Failure; Dysautonomia; Cognitive Impairment; Ehlers-Danlos Syndrome; Postural Tachycardia Syndrome; Pure Autonomic Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• blood pressure Change (mmHg)

  during intervention (Leg crossing)

• Heart frequency Change (B/min)

  during intervention (Leg crossing)

• cerebral blood flow velocity

  during intervention (Leg crossing)

Study Arms (3)

lying

NO INTERVENTION

cognitive tests are performed during lying in all groups (SFN, AAN, EDS, POTS and controls)

standing

NO INTERVENTION

cognitive tests are performed during active Standing in all groups (SFN, AAN, EDS, POTS and controls)

crossed legs

EXPERIMENTAL

cognitive tests are performed during leg crossing in all groups (SFN, AAN, EDS, POTS and controls)

Procedure: leg crossing

Interventions

leg crossing PROCEDURE

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

crossed legs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (6)

• 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.

  PMID: 25510829 BACKGROUND

• 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.

  PMID: 25009504 BACKGROUND

• 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.

  PMID: 25001527 BACKGROUND

• 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.

  PMID: 22158721 BACKGROUND

• 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.

  PMID: 24465471 BACKGROUND

• 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 Aug;33(4):459-468. doi: 10.1007/s10286-023-00950-0. Epub 2023 Jun 1.

  PMID: 37261636 RESULT

MeSH Terms

Conditions

Pure Autonomic Failure; Autonomic Nervous System Diseases; Cognitive Dysfunction; Ehlers-Danlos Syndrome; Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Orthostatic Intolerance

Study Officials

• Andrea Maier, Dr.

  Universitiy hospital RWTH Aachen, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Andrea Maier, Principal Investigator

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 21, 2018
• Study Start: April 1, 2017
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)