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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01659398
First received: August 3, 2012
Last updated: February 3, 2014
Last verified: January 2014
  Purpose

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:

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 ]

Estimated Enrollment: 10
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)
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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659398

Contacts
Contact: Julie-Ann Dutton, MS, RD (913) 588-4064 JDUTTON@kumc.edu

Locations
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         
Sponsors and Collaborators
Patrick Moriarty, MD, FACP, FACC
Investigators
Principal Investigator: Patrick Moriarty, MD University of Kansas
  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: February 3, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014