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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: External Counterpulsation (EECP) Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
Study Start Date : June 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change in Ophthalmic blood flow (OBF) [ Time Frame: Baseline to Week 7 ]
  2. Change in Blood Viscosity [ Time Frame: Baseline to Week 7 ]
  3. Cholesterol composition of the blood [ Time Frame: Baseline to week 7 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Additional Information:
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
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center Research Institute:
Alzheimer's Disease
cerebral blood flow
ophthalmic blood flow
blood viscosity

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders