Cognitive Dysfunction in Postural Tachycardia Syndrome

NCT01366963 | Completed

• 1 other identifier: 101401
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postural Tachycardia Syndrome

Keywords

postural tachycardia syndrome; brain fog; cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Cognitive Domain Score (CDS)

  At seated and standing. This is a cross-sectional study without follow-up. All assessments are performed on a single day.

Study Arms (2)

Normal Controls / Healthy Volunteers

Age and gender matched individuals without postural orthostatic tachycardia syndrome

Behavioral: Seated Measurements; Behavioral: Standing Measurements; Behavioral: Self-Administered Surveys

Patients with Postural Tachycardia Syndrome (POTS)

Individuals with Postural Tachycardia Syndrome

Behavioral: Seated Measurements; Behavioral: Standing Measurements; Behavioral: Self-Administered Surveys

Interventions

Seated Measurements BEHAVIORAL

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)

Normal Controls / Healthy Volunteers; Patients with Postural Tachycardia Syndrome (POTS)

Standing Measurements BEHAVIORAL

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

Normal Controls / Healthy Volunteers; Patients with Postural Tachycardia Syndrome (POTS)

Self-Administered Surveys BEHAVIORAL

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

Normal Controls / Healthy Volunteers; Patients with Postural Tachycardia Syndrome (POTS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• All
• Ages between 18-60 years
• Male and female subjects are eligible
• Able and willing to provide informed consent
• Gender matched to POTS patients
• Age-matched to POTS patients (+/- 5 years of a POTS patient)
• Grossly matched in intelligence to POTS patients

You may not qualify if:

• 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.
• \- Overt cause for postural tachycardia (such as acute dehydration)
• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (12)

• 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.

  PMID: 18977825 BACKGROUND

• 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. doi: 10.2466/pms.1992.75.3f.1311.

  PMID: 1484803 BACKGROUND

• 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. doi: 10.1016/j.acn.2007.06.005. Epub 2007 Jul 20.

  PMID: 17640850 BACKGROUND

• Tombaugh 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.

  PMID: 15010086 BACKGROUND

• 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.

  PMID: 14588937 BACKGROUND

• 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. doi: 10.1097/00006842-197806000-00004.

  PMID: 356080 BACKGROUND

• 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. doi: 10.1016/j.janxdis.2005.04.001. Epub 2005 Jun 1.

  PMID: 15935611 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Mental Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Satish Raj, MD, MSCI

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: June 6, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)