Autonomic FailurePOTSKogNCT03681080
Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies
A study testing leg crossing in people with Autonomic Failure and Dysautonomia, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Failure, Dysautonomia, Cognitive Impairment
- What is being tested?
- leg crossing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital, RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Understanding Impaired Concentration, Attentional Deficits and Their Pathophysiology in Postural Orthostatic Tachycardia Syndrome (POTS) and Other Autonomic Neuropathies (POTSKog-Study Aachen)
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).
Read the 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.
- Conditions
- Autonomic Failure, Dysautonomia, Cognitive Impairment, Ehlers-Danlos Syndrome, Postural Tachycardia Syndrome, Pure Autonomic Failure
- Being tested
- leg crossing
- Medical subject headings
- Pure Autonomic Failure, Autonomic Nervous System Diseases, Cognitive Dysfunction, Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg crossingProcedure or surgery
As Counter maneuvre legs will be crossed and cognitive tests will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: leg crossing |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function: Stroop, TMT A und B
Change of results of cognitive function tests lying compared to standing and leg crossing
Measured: during intervention (Leg crossing)
Secondary outcomes (3)
blood pressure Change (mmHg)
Change between blood pressure lying compared to compared to standing and leg crossing
Measured: during intervention (Leg crossing)
Heart frequency Change (B/min)
Change between heart frequency lying compared to compared to standing and leg crossing
Measured: during intervention (Leg crossing)
cerebral blood flow velocity
Change between cerebral blood flow compared to compared to standing and leg crossing
Measured: during intervention (Leg crossing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Apr 2017
- Primary completion30 May 2021
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autonomic FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Maier, RWTH Aachen University
- Investigators
- Andrea Maier, Dr., Principal investigator, Universitiy hospital RWTH Aachen, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681080
- Sponsor's protocol ID
- 17-006
- Acronym
- POTSKog
- Status last verified
- Jun 2023
- First submitted
- 10 Sep 2018
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25510829Anderson 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.
PubMed 25009504Arnold 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.
PubMed 25001527Gibbons 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.
PubMed 22158721Guaraldi 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.
PubMed 24465471Maier 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.
PubMed 37261636
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Impaired Concentration, Attentional Deficits and Their Pathophysiology in Postural Orthostatic Tachycardia Syndrome (POTS) and Other Autonomic Neuropathies (POTSKog-Study Aachen)
- ClinicalTrials.gov ID
- NCT03681080
- Acronym / sponsor ID
- POTSKog / 17-006
- Conditions
- Autonomic Failure, Dysautonomia, Cognitive Impairment, Ehlers-Danlos Syndrome, Postural Tachycardia Syndrome, Pure Autonomic Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: leg crossingcognitive tests are performed during leg crossing in all groups (SFN, AAN, EDS, POTS and controls) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leg crossingAs Counter maneuvre legs will be crossed and cognitive tests will be performed. | Procedure or surgery | crossed legs |
Primary outcome
cognitive function: Stroop, TMT A und B
Time frame: during intervention (Leg crossing)
Change of results of cognitive function tests lying compared to standing and leg crossing
3 secondary outcomes
blood pressure Change (mmHg)
Time frame: during intervention (Leg crossing)
Heart frequency Change (B/min)
Time frame: during intervention (Leg crossing)
cerebral blood flow velocity
Time frame: during intervention (Leg crossing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Background: PubMed 25510829Stewart 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.
- Background: PubMed 25009504Anderson 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.
- Background: PubMed 25001527Arnold 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.
- Background: PubMed 22158721Gibbons 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.
- Background: PubMed 24465471Guaraldi 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 publication: PubMed 37261636Maier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Maier, Dr. principal investigator
Universitiy hospital RWTH Aachen, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leg crossing in people with Autonomic Failure and Dysautonomia, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function: Stroop, TMT A und B (time frame: during intervention (Leg crossing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03681080, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.