Cognitive Dysfunction in Postural Tachycardia Syndrome
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postural Tachycardia Syndrome |
Behavioral: Seated Measurements Behavioral: Standing Measurements Behavioral: Self-Administered Surveys |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Origins of Cognitive Dysfunction in Postural Tachycardia Syndrome (POTS) |
- Standing Digits Backwards Test [ Time Frame: In the standing position for approximately 15 minutes. This is a cross-sectional study with no follow-up. ] [ Designated as safety issue: No ]This is a continuous variable that will provide a measure of attention with orthostatic stress.
- 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. ] [ Designated as safety issue: No ]
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).
2. 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).
| Estimated Enrollment: | 85 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Normal Controls / Healthy Volunteers
Age and gender matched individuals without postural orthostatic tachycardia syndrome
|
Behavioral: Seated Measurements
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) 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 Center for Epidemiologic Studies Depression Scale (CES-D) Cognitive-Somatic Anxiety Questionnaire (CSAQ) Subjective Neurocognitive Inventory (SNI)
|
|
Patients with Postural Tachycardia Syndrome (POTS)
Individuals with Postural Tachycardia Syndrome
|
Behavioral: Seated Measurements
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) 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 Center for Epidemiologic Studies Depression Scale (CES-D) Cognitive-Somatic Anxiety Questionnaire (CSAQ) Subjective Neurocognitive Inventory (SNI)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Patients having been diagnosed with postural tachycardia syndrome and age & gender matched normal controls
Inclusion Criteria:
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
- Gender matched to POTS patients
- Age-matched to POTS patients (+/- 5 years of a POTS patient)
- Grossly matched in intelligence to POTS patients
Exclusion Criteria:
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)
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
Contacts and Locations| Contact: Satish Raj, MD, MSCI | 615-322-2931 | adcresearch@vanderbilt.edu |
| Contact: Kirsten Haman, PhD | 615-343-2572 | adcresearch@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Satish Raj, MD, MSCI 615-322-2931 adcresesarch@vanderbilt.edu | |
| Contact: Kirsten Haman, PhD 615-343-2572 adcresearch@vanderbilt.edu | |
| Principal Investigator: | Satish Raj, MD, MSCI | Vanderbilt University |
More Information
Additional Information:
Publications:
| Responsible Party: | Satish R. Raj, Assistant Professor of Medicine, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01366963 History of Changes |
| Other Study ID Numbers: | 101401, R01 HL102387 |
| Study First Received: | February 17, 2011 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
postural tachycardia syndrome brain fog cognitive dysfunction |
Additional relevant MeSH terms:
|
Tachycardia Cognition Disorders Postural Orthostatic Tachycardia Syndrome Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013