Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2011-03-31
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal Controls / Healthy Volunteers
Age and gender matched individuals without postural orthostatic tachycardia syndrome
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)
Patients with Postural Tachycardia Syndrome (POTS)
Individuals with Postural Tachycardia Syndrome
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Satish R. Raj
Assistant Professor of Medicine
Principal Investigators
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Satish Raj, MD, MSCI
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Vanderbilt University
Nashville, Tennessee, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Lezak 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.
Other Identifiers
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101401
Identifier Type: -
Identifier Source: org_study_id
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