Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
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|ClinicalTrials.gov Identifier: NCT01659398|
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : January 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Device: External Counterpulsation (EECP)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|Experimental: Enhanced external counterpulsation (EECP)||
Device: External Counterpulsation (EECP)
A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week.
No Intervention: Subjects not receiving EECP
Control group to measure data from experimental group against.
- Change in Cognitive Function [ Time Frame: Baseline, Week 7, 6 Month ]Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment).
- Change in Ophthalmic blood flow (OBF) [ Time Frame: Baseline to Week 7 ]
- Change in Blood Viscosity [ Time Frame: Baseline to Week 7 ]
- Cholesterol composition of the blood [ Time Frame: Baseline to week 7 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659398
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Patrick Moriarty, MD||University of Kansas Medical Center|