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OpenTrials
Completed

NCT Number: NCT01659398

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External Counterpulsation (EECP)

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Patrick Moriarty, MD, FACP, FACC

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2012
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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