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

Last updated: January 12, 2016
Sponsor: Patrick Moriarty, MD, FACP, FACC
Overall Status: Completed

Phase

1

Condition

Dementia

Mental Disability

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT01659398
13106
  • Ages 18-85
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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, surgicallysterile or using an effective form of contraception).

  • Able to speak and read English.

  • Willing to comply with study specific instructions, and complete all study proceduresaccording to protocol.

  • Able to understand study rationale and sign informed consent.

Exclusion

Exclusion Criteria:

  • Diagnosed with glaucoma

  • History of developing adverse effects to ophthalmic dilating agents (phenylephrine ortropicamide).

  • 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.

Study Design

Total Participants: 8
Study Start date:
June 01, 2012
Estimated Completion Date:
October 31, 2014

Connect with a study center

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

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