Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients

This study has been completed.
Information provided by (Responsible Party):
Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
First received: August 3, 2012
Last updated: October 13, 2015
Last verified: October 2015
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).

Condition Intervention
Mild Cognitive Impairment
Device: External Counterpulsation (EECP)

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: June 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • An adult between 18 and 85 years of age.
  • Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
  • Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
  • Able to speak and read English.
  • Willing to comply with study specific instructions, and complete all study procedures according to protocol.
  • Able to understand study rationale and sign informed consent.

Exclusion Criteria:

  • Diagnosed with glaucoma
  • History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
  • Currently taking warfarin and dabigatran (Pradaxa).
  • History of having arrhythmias - can interfere with EECP triggering.
  • Subject has bleeding diathesis.
  • Subject has active thrombophlebitis.
  • Subject has severe lower extremity vaso-occlusive disease.
  • Subject has a documented aortic aneurysm requiring surgical repair.
  • Subject is pregnant.
  • Subject with blood pressure higher than 180/110 mmHg.
  • Subject with a heart rate more than 120 bpm.
  • Subject with high risk of complications from increased venous return.
  • Subject with clinically significant valvular disease.
  • Subjects with severe vascular disease as established by the Hachinski Ischemic Index.
  • Subjects with pacemakers and other metallic implantable devices.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01659398

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Patrick Moriarty, MD, FACP, FACC
Principal Investigator: Patrick Moriarty, MD University of Kansas Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Patrick Moriarty, MD, FACP, FACC, Director, Clinical Pharmacology, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01659398     History of Changes
Other Study ID Numbers: 13106
Study First Received: August 3, 2012
Last Updated: October 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
Alzheimer's Disease
cerebral blood flow
ophthalmic blood flow
blood viscosity

Additional relevant MeSH terms:
Mild Cognitive Impairment
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 27, 2015