Cognitive Dysfunction in Postural Tachycardia Syndrome

Postural Tachycardia Syndrome Clinical Trial

Official title:

Origins of Cognitive Dysfunction in Postural Tachycardia Syndrome (POTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366963
• Other study ID #: 101401
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: August 15, 2016
• Start date: March 2011
• Est. completion date: June 2015

Study information

• Verified date: August 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. The investigators hypothesis is that people with POTS will have greater abnormalities on neuropsychiatric testing than normal controls.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

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)
• 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
• Self-Administered Surveys
Center for Epidemiologic Studies Depression Scale (CES-D) Cognitive-Somatic Anxiety Questionnaire (CSAQ) Subjective Neurocognitive Inventory (SNI)

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (12)

Lezak MD, Howieson DB, Oring DW, Annay HJ, Isher JS. Neuropsychological Assessment. New York:Oxford University Press;2004

Messinis 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. Epub 2007 Jul 20. — View Citation

Moritz 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. Epub 2005 Jun 1. — View Citation

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.

Radloff LS. The CES-D Scale: A self-report depression scale for resarch in the general population. Applied Psychological Measurement 1077;1:385-401.

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. — View Citation

Ruff 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. — View Citation

Ruff 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. — View Citation

Schwartz 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. — View Citation

Smith A. Symbol Digit Modalitites Test.Los Angeles:Western Psychological Services; 1982.

Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. — View Citation

Wechsler D. The Wechsler Test of Adult Reading. San Antonio, Texas: PsychCorp;2001.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standing Digits Backwards Test	This is a continuous variable that will provide a measure of attention with orthostatic stress.	In the standing position for approximately 15 minutes. This is a cross-sectional study with no follow-up.	No
Secondary	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).; 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).	At seated and standing. This is a cross-sectional study without follow-up. All assessments are performed on a single day.	No

External Links

•   Vanderbilt Autonomic Dysfunction Center - Current Research Projects