Postural Tachycardia SyndromeNCT01366963
Cognitive Dysfunction in Postural Tachycardia Syndrome
An observational study of Postural Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
A common complaint among people with Postural Tachycardia Syndrome (POTS) is "brain fog" or difficulty concentrating. This is very poorly understood. To better understand this cognitive dysfunction, the investigators will test people with POTS and people without POTS using various neuropsychiatric instruments. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- Seated Measurements, Standing Measurements and Self-Administered Surveys
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2015
- Phase
- Observational
- 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
Study population: Patients having been diagnosed with postural tachycardia syndrome and age \& gender matched normal controls
Who may be able to join
- All
- Ages between 18-60 years
- Male and female subjects are eligible
- Able and willing to provide informed consent
- POTS - additional inclusion criteria - Diagnosed with postural tachycardia syndrome by Vanderbilt Autonomic Dysfunction Center (increase in heart rate greater than or equal to 30 beats per minute with position change from supine to standing (10 minutes; chronic symptoms consistent with POTS that are worse when upright and get better with recumbence.)
- Control subjects - additional inclusion criteria
Show all 9Show fewer
- Gender matched to POTS patients
- Age-matched to POTS patients (+/- 5 years of a POTS patient)
- Grossly matched in intelligence to POTS patients
Who cannot join
- ALL
- Inability to give or withdrawal of informed consent
- Pregnancy (determined by patient self report)
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
- POTS - additional exclusion criteria
- Overt cause for postural tachycardia (such as acute dehydration)
Show all 14Show fewer
- Normal Controls - additional exclusion criteria
- Previously diagnosed with Axis I psychiatric disorder
- Previously diagnosed learning disorder
- Previously diagnosed attention deficit hyperactivity disorder (ADHD)
- Prior psychosis
- past or present substance abuse
- History of loss of consciousness
- History of seizures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Origins of Cognitive Dysfunction in Postural Tachycardia Syndrome (POTS)
A common complaint among people with Postural Tachycardia Syndrome (POTS) is "brain fog" or difficulty concentrating. This is very poorly understood. To better understand this cognitive dysfunction, the investigators will test people with POTS and people without POTS using various neuropsychiatric instruments. The investigators hypothesis is that people with POTS will have greater abnormalities on neuropsychiatric testing than normal controls.
Read the detailed description
Postural Tachycardia Syndrome (POTS) is a disorder that affects an estimated 500,000 people in the United States alone and is an important source of disability in young adults. It shows a strong predilection for females. POTS is a form of orthostatic intolerance characterized by an excessive increase in heart rate (>30 bpm) on assuming the upright position associated with orthostatic symptoms, but in the absence of orthostatic hypotension. Their symptoms of dizziness, nausea, tremor, chronic fatigue and exercise intolerance make even simple activities of daily living exhausting prospects.
Brain fog or cognitive dysfunction is a common and almost universal complaint among persons with POTS. There is a lack of pathophysiological understanding to this cognitive dysfunction and is also a major roadblock to the development of effective therapies for people with POTS.
The purpose of this study is to better define the cognitive dysfunction seen in patients with POTS. We will use a series of validated neuropsychological tools in order to characterize POTS cognitive dysfunction and compare this data to age and gender matched control subjects.
Specific Aims:
- To assess whether POTS patients have more neuropsychological abnormalities than control subjects during seated assessments.
- To assess whether POTS patients have more neuropsychological abnormalities than control subjects during assessments while standing.
- To ascertain the phenomenology of any neuropsychological deficits distinguishing POTS patients from controls.
- Conditions
- Postural Tachycardia Syndrome
- Being tested
- Seated Measurements, Standing Measurements, Self-Administered Surveys
- Keywords
- postural tachycardia syndrome, brain fog, cognitive dysfunction
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Mental Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated MeasurementsBehavioural
The following measurements will take place in a seated position:
Ruff 1 \& 7 (visual search and attention processes) Trails A \& B (Tests of scanning, mental flexibility and executive processes) Symbol Digit Modalities Test (SDMT)(attention and psychomotor speed) Stroop Test (naming response to certain stimuli) Verbal Fluency (COWA) Randt Wechsler Test of Adult Reading (WTAR)
Standing MeasurementsBehavioural
The following will be measured in a standing position (at least 5 minutes)
Orthostatic Vital Signs Randt Paired Words Subtest Digits Forward and Backward Alternate COWA test
Self-Administered SurveysBehavioural
Center for Epidemiologic Studies Depression Scale (CES-D) Cognitive-Somatic Anxiety Questionnaire (CSAQ) Subjective Neurocognitive Inventory (SNI)
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls / Healthy Volunteers | Age and gender matched individuals without postural orthostatic tachycardia syndrome Receives: Behavioral: Seated Measurements; Behavioral: Standing Measurements; Behavioral: Self-Administered Surveys | |
| Patients with Postural Tachycardia Syndrome (POTS) | Individuals with Postural Tachycardia Syndrome Receives: Behavioral: Seated Measurements; Behavioral: Standing Measurements; Behavioral: Self-Administered Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standing Digits Backwards Test
This is a continuous variable that will provide a measure of attention with orthostatic stress.
Measured: In the standing position for approximately 15 minutes. This is a cross-sectional study with no follow-up.
Secondary outcomes (1)
Cognitive Domain Score (CDS)
The CDS will consist of
1: Seated memory (Randt Short Story subtes, Paired words subtes and Digits Forward) and standing memory (Randt short story, paired words and digits forward).
- Seated Complex Attention (Ruff, SDMT, Trails A, Randt, Digits Backward) and standing complex attention (Randt digits backward) 3. Executive functioning only while standing (Stroop, Trails) 4. Seated and standing verbal fluency (COWA).
Measured: At seated and standing. This is a cross-sectional study without follow-up. All assessments are performed on a single day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postural Tachycardia SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish R. Raj, Vanderbilt University
- Investigators
- Satish Raj, MD, MSCI, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366963
- Sponsor's protocol ID
- 101401
- Status last verified
- Aug 2016
- First submitted
- 17 Feb 2011
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Raj V, Haman KL, Raj SR, Byrne D, Blakely RD, Biaggioni I, Robertson D, Shelton RC. Psychiatric profile and attention deficits in postural tachycardia syndrome. J Neurol Neurosurg Psychiatry. 2009 Mar;80(3):339-44. doi: 10.1136/jnnp.2008.144360. Epub 2008 Oct 31.
PubMed 18977825Ruff RM, Niemann H, Allen CC, Farrow CE, Wylie T. The Ruff 2 and 7 Selective Attention Test: a neuropsychological application. Percept Mot Skills. 1992 Dec;75(3 Pt 2):1311-9. doi: 10.2466/pms.1992.75.3f.1311.
PubMed 1484803Messinis L, Kosmidis MH, Tsakona I, Georgiou V, Aretouli E, Papathanasopoulos P. Ruff 2 and 7 Selective Attention Test: normative data, discriminant validity and test-retest reliability in Greek adults. Arch Clin Neuropsychol. 2007 Aug;22(6):773-85. doi: 10.1016/j.acn.2007.06.005. Epub 2007 Jul 20.
PubMed 17640850Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. doi: 10.1016/S0887-6177(03)00039-8.
PubMed 15010086Ruff RM, Light RH, Parker SB, Levin HS. Benton Controlled Oral Word Association Test: reliability and updated norms. Arch Clin Neuropsychol. 1996;11(4):329-38.
PubMed 14588937Schwartz GE, Davidson RJ, Goleman DJ. Patterning of cognitive and somatic processes in the self-regulation of anxiety: effects of meditation versus exercise. Psychosom Med. 1978 Jun;40(4):321-8. doi: 10.1097/00006842-197806000-00004.
PubMed 356080Moritz S, Kuelz AK, Jacobsen D, Kloss M, Fricke S. Severity of subjective cognitive impairment in patients with obsessive-compulsive disorder and depression. J Anxiety Disord. 2006;20(4):427-43. doi: 10.1016/j.janxdis.2005.04.001. Epub 2005 Jun 1.
PubMed 15935611Lezak MD, Howieson DB, Oring DW, Annay HJ, Isher JS. Neuropsychological Assessment. New York:Oxford University Press;2004
Smith A. Symbol Digit Modalitites Test.Los Angeles:Western Psychological Services; 1982.
Wechsler D. The Wechsler Test of Adult Reading. San Antonio, Texas: PsychCorp;2001.
Radloff LS. The CES-D Scale: A self-report depression scale for resarch in the general population. Applied Psychological Measurement 1077;1:385-401.
Putzke JD, Williams MA, Daniel FJ, Bourge RC, Boll TJ. Self-report versus performance based activities of daily living capacity among heart transplanta candidates and their caregivers. Journal of Clinical Psychology in Medical Settings 2000;7:121-32.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Origins of Cognitive Dysfunction in Postural Tachycardia Syndrome (POTS)
- ClinicalTrials.gov ID
- NCT01366963
- Acronym / sponsor ID
- 101401
- Conditions
- Postural Tachycardia Syndrome
- Keywords
- postural tachycardia syndrome, brain fog, cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Jun 2011 (estimated)
- 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.
A common complaint among people with Postural Tachycardia Syndrome (POTS) is "brain fog" or difficulty concentrating. This is very poorly understood. To better understand this cognitive dysfunction, the investigators will test people with POTS and people without POTS using various neuropsychiatric instruments. The investigators hypothesis is that people with POTS will have greater abnormalities on neuropsychiatric testing than normal controls.
Detailed description
Postural Tachycardia Syndrome (POTS) is a disorder that affects an estimated 500,000 people in the United States alone and is an important source of disability in young adults. It shows a strong predilection for females. POTS is a form of orthostatic intolerance characterized by an excessive increase in heart rate (>30 bpm) on assuming the upright position associated with orthostatic symptoms, but in the absence of orthostatic hypotension. Their symptoms of dizziness, nausea, tremor, chronic fatigue and exercise intolerance make even simple activities of daily living exhausting prospects.
Brain fog or cognitive dysfunction is a common and almost universal complaint among persons with POTS. There is a lack of pathophysiological understanding to this cognitive dysfunction and is also a major roadblock to the development of effective therapies for people with POTS.
The purpose of this study is to better define the cognitive dysfunction seen in patients with POTS. We will use a series of validated neuropsychological tools in order to characterize POTS cognitive dysfunction and compare this data to age and gender matched control subjects.
Specific Aims:
- To assess whether POTS patients have more neuropsychological abnormalities than control subjects during seated assessments.
- To assess whether POTS patients have more neuropsychological abnormalities than control subjects during assessments while standing.
- To ascertain the phenomenology of any neuropsychological deficits distinguishing POTS patients from controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Controls / Healthy Volunteers | – | Behavioral: Seated Measurements, Behavioral: Standing Measurements, Behavioral: Self-Administered SurveysAge and gender matched individuals without postural orthostatic tachycardia syndrome |
| Patients with Postural Tachycardia Syndrome (POTS) | – | Behavioral: Seated Measurements, Behavioral: Standing Measurements, Behavioral: Self-Administered SurveysIndividuals with Postural Tachycardia Syndrome |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients having been diagnosed with postural tachycardia syndrome and age \& gender matched normal controls
Key inclusion criteria (9 listed)
- All
- Ages between 18-60 years
- Male and female subjects are eligible
- Able and willing to provide informed consent
- POTS - additional inclusion criteria - Diagnosed with postural tachycardia syndrome by Vanderbilt Autonomic Dysfunction Center (increase in heart rate greater than or equal to 30 beats per minute with position change from supine to standing (10 minutes; chronic symptoms consistent with POTS that are worse when upright and get better with recumbence.)
Key exclusion criteria (14 listed)
- ALL
- Inability to give or withdrawal of informed consent
- Pregnancy (determined by patient self report)
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
- POTS - additional exclusion criteria
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 |
|---|---|---|
| Seated MeasurementsThe following measurements will take place in a seated position: Ruff 1 \& 7 (visual search and attention processes) Trails A \& B (Tests of scanning, mental flexibility and executive processes) Symbol Digit Modalities Test (SDMT)(attention and psychomotor speed) Stroop Test (naming response to certain stimuli) Verbal Fluency (COWA) Randt Wechsler Test of Adult Reading (WTAR) | Behavioural | Normal Controls / Healthy Volunteers, Patients with Postural Tachycardia Syndrome (POTS) |
| Standing MeasurementsThe following will be measured in a standing position (at least 5 minutes) Orthostatic Vital Signs Randt Paired Words Subtest Digits Forward and Backward Alternate COWA test | Behavioural | Normal Controls / Healthy Volunteers, Patients with Postural Tachycardia Syndrome (POTS) |
| Self-Administered SurveysCenter for Epidemiologic Studies Depression Scale (CES-D) Cognitive-Somatic Anxiety Questionnaire (CSAQ) Subjective Neurocognitive Inventory (SNI) | Behavioural | Normal Controls / Healthy Volunteers, Patients with Postural Tachycardia Syndrome (POTS) |
Primary outcome
Standing Digits Backwards Test
Time frame: In the standing position for approximately 15 minutes. This is a cross-sectional study with no follow-up.
This is a continuous variable that will provide a measure of attention with orthostatic stress.
1 secondary outcome
Cognitive Domain Score (CDS)
Time frame: At seated and standing. This is a cross-sectional study without follow-up. All assessments are performed on a single day.
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 17 Aug 2016.
- Background: PubMed 18977825Raj V, Haman KL, Raj SR, Byrne D, Blakely RD, Biaggioni I, Robertson D, Shelton RC. Psychiatric profile and attention deficits in postural tachycardia syndrome. J Neurol Neurosurg Psychiatry. 2009 Mar;80(3):339-44. doi: 10.1136/jnnp.2008.144360. Epub 2008 Oct 31.
- Background: PubMed 1484803Ruff RM, Niemann H, Allen CC, Farrow CE, Wylie T. The Ruff 2 and 7 Selective Attention Test: a neuropsychological application. Percept Mot Skills. 1992 Dec;75(3 Pt 2):1311-9. doi: 10.2466/pms.1992.75.3f.1311.
- Background: PubMed 17640850Messinis L, Kosmidis MH, Tsakona I, Georgiou V, Aretouli E, Papathanasopoulos P. Ruff 2 and 7 Selective Attention Test: normative data, discriminant validity and test-retest reliability in Greek adults. Arch Clin Neuropsychol. 2007 Aug;22(6):773-85. doi: 10.1016/j.acn.2007.06.005. Epub 2007 Jul 20.
- Background: PubMed 15010086Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. doi: 10.1016/S0887-6177(03)00039-8.
- Background: PubMed 14588937Ruff RM, Light RH, Parker SB, Levin HS. Benton Controlled Oral Word Association Test: reliability and updated norms. Arch Clin Neuropsychol. 1996;11(4):329-38.
- Background: PubMed 356080Schwartz GE, Davidson RJ, Goleman DJ. Patterning of cognitive and somatic processes in the self-regulation of anxiety: effects of meditation versus exercise. Psychosom Med. 1978 Jun;40(4):321-8. doi: 10.1097/00006842-197806000-00004.
- Background: PubMed 15935611Moritz S, Kuelz AK, Jacobsen D, Kloss M, Fricke S. Severity of subjective cognitive impairment in patients with obsessive-compulsive disorder and depression. J Anxiety Disord. 2006;20(4):427-43. doi: 10.1016/j.janxdis.2005.04.001. Epub 2005 Jun 1.
- BackgroundLezak MD, Howieson DB, Oring DW, Annay HJ, Isher JS. Neuropsychological Assessment. New York:Oxford University Press;2004
- BackgroundSmith A. Symbol Digit Modalitites Test.Los Angeles:Western Psychological Services; 1982.
- BackgroundWechsler D. The Wechsler Test of Adult Reading. San Antonio, Texas: PsychCorp;2001.
- BackgroundRadloff LS. The CES-D Scale: A self-report depression scale for resarch in the general population. Applied Psychological Measurement 1077;1:385-401.
- BackgroundPutzke JD, Williams MA, Daniel FJ, Bourge RC, Boll TJ. Self-report versus performance based activities of daily living capacity among heart transplanta candidates and their caregivers. Journal of Clinical Psychology in Medical Settings 2000;7:121-32.
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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.
Satish Raj, MD, MSCI principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
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 9 inclusion and 14 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 17 Aug 2016. 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 United States. 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?
Standing Digits Backwards Test (time frame: In the standing position for approximately 15 minutes. This is a cross-sectional study with no follow-up.). 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 NCT01366963, which also lists 12 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 17 Aug 2016; AzTrials last refreshed its copy on 27 Oct 2026.