Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2023-05-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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lying

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

Group Type NO_INTERVENTION

No interventions assigned to this group

standing

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

Group Type NO_INTERVENTION

No interventions assigned to this group

crossed legs

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

Group Type EXPERIMENTAL

leg crossing

Intervention Type PROCEDURE

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

Interventions

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leg crossing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes