Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies (POTSKog)
Primary Purpose
Autonomic Failure, Dysautonomia, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
leg crossing
Sponsored by
About this trial
This is an interventional supportive care trial for Autonomic Failure
Eligibility Criteria
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
Sites / Locations
- University Hospital, RWTH Aachen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Experimental
Arm Label
lying
standing
crossed legs
Arm Description
cognitive tests are performed during lying in all groups (SFN, AAN, EDS, POTS and controls)
cognitive tests are performed during active Standing in all groups (SFN, AAN, EDS, POTS and controls)
cognitive tests are performed during leg crossing in all groups (SFN, AAN, EDS, POTS and controls)
Outcomes
Primary Outcome Measures
cognitive function: Stroop, TMT A und B
Change of results of cognitive function tests lying compared to standing and leg crossing
Secondary Outcome Measures
blood pressure Change (mmHg)
Change between blood pressure lying compared to compared to standing and leg crossing
Heart frequency Change (B/min)
Change between heart frequency lying compared to compared to standing and leg crossing
cerebral blood flow velocity
Change between cerebral blood flow compared to compared to standing and leg crossing
Full Information
NCT ID
NCT03681080
First Posted
September 10, 2018
Last Updated
June 23, 2023
Sponsor
RWTH Aachen University
1. Study Identification
Unique Protocol Identification Number
NCT03681080
Brief Title
Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies
Acronym
POTSKog
Official Title
Understanding Impaired Concentration, Attentional Deficits and Their Pathophysiology in Postural Orthostatic Tachycardia Syndrome (POTS) and Other Autonomic Neuropathies (POTSKog-Study Aachen)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Failure, Dysautonomia, Cognitive Impairment, Ehlers-Danlos Syndrome, Postural Tachycardia Syndrome, Pure Autonomic Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lying
Arm Type
No Intervention
Arm Description
cognitive tests are performed during lying in all groups (SFN, AAN, EDS, POTS and controls)
Arm Title
standing
Arm Type
No Intervention
Arm Description
cognitive tests are performed during active Standing in all groups (SFN, AAN, EDS, POTS and controls)
Arm Title
crossed legs
Arm Type
Experimental
Arm Description
cognitive tests are performed during leg crossing in all groups (SFN, AAN, EDS, POTS and controls)
Intervention Type
Procedure
Intervention Name(s)
leg crossing
Intervention Description
As Counter maneuvre legs will be crossed and cognitive tests will be performed.
Primary Outcome Measure Information:
Title
cognitive function: Stroop, TMT A und B
Description
Change of results of cognitive function tests lying compared to standing and leg crossing
Time Frame
during intervention (Leg crossing)
Secondary Outcome Measure Information:
Title
blood pressure Change (mmHg)
Description
Change between blood pressure lying compared to compared to standing and leg crossing
Time Frame
during intervention (Leg crossing)
Title
Heart frequency Change (B/min)
Description
Change between heart frequency lying compared to compared to standing and leg crossing
Time Frame
during intervention (Leg crossing)
Title
cerebral blood flow velocity
Description
Change between cerebral blood flow compared to compared to standing and leg crossing
Time Frame
during intervention (Leg crossing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Maier, Dr.
Organizational Affiliation
Universitiy hospital RWTH Aachen, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, RWTH Aachen
City
Aachen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25510829
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.
Results Reference
background
PubMed Identifier
25009504
Citation
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.
Results Reference
background
PubMed Identifier
25001527
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.
Results Reference
background
PubMed Identifier
22158721
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.
Results Reference
background
PubMed Identifier
24465471
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.
Results Reference
background
PubMed Identifier
37261636
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 Aug;33(4):459-468. doi: 10.1007/s10286-023-00950-0. Epub 2023 Jun 1.
Results Reference
result
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Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies
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