Cognitive Dysfunction in Postural Tachycardia Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01366963
First received: February 17, 2011
Last updated: January 7, 2013
Last verified: January 2013
  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)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)

Behavioral: Standing Measurements

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

Behavioral: Self-Administered Surveys
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)

Behavioral: Standing Measurements

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

Behavioral: Self-Administered Surveys
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:

  1. To assess whether POTS patients have more neuropsychological abnormalities than control subjects during seated assessments.
  2. To assess whether POTS patients have more neuropsychological abnormalities than control subjects during assessments while standing.
  3. 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
Study Population

Patients having been diagnosed with postural tachycardia syndrome and age & gender matched normal controls

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366963

Contacts
Contact: Satish Raj, MD, MSCI 615-322-2931 adcresearch@vanderbilt.edu
Contact: Kirsten Haman, PhD 615-343-2572 adcresearch@vanderbilt.edu

Locations
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   
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Satish Raj, MD, MSCI Vanderbilt University
  More Information

Additional Information:
Publications:
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.

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:
Syndrome
Tachycardia
Cognition Disorders
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014