Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients|
- Change in Cognitive Function [ Time Frame: Baseline, Week 7, 6 Month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Change in Blood Viscosity [ Time Frame: Baseline to Week 7 ] [ Designated as safety issue: No ]
- Cholesterol composition of the blood [ Time Frame: Baseline to week 7 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659398
|Contact: Julie-Ann Dutton, MS, RD||(913) 588-4064||JDUTTON@kumc.edu|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Julie-Ann Dutton, MS, RD 913-588-4064 JDUTTON@kumc.edu|
|Principal Investigator: Patrick Moriarty, MD|
|Principal Investigator:||Patrick Moriarty, MD||University of Kansas|