Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

Not Applicable

Completed

• Conditions: Ehlers-Danlos Syndrome; Dysautonomia; Cognitive Impairment; Pure Autonomic Failure; Autonomic Failure; Postural Tachycardia Syndrome
• Interventions: Procedure: leg crossing

• Registration Number: NCT03681080
• Lead Sponsor: 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).

Detailed 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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Primary Completion: 2021-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
crossed legs	leg crossing	cognitive tests are performed during leg crossing in all groups (SFN, AAN, EDS, POTS and controls)

Primary Outcome Measures

Name	Time	Method
cognitive function: Stroop, TMT A und B	during intervention (Leg crossing)	Change of results of cognitive function tests lying compared to standing and leg crossing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital, RWTH Aachen; 🇩🇪 Aachen, Nordrhein Westfalen, Germany