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



Status:Completed
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:June 2012
End Date:October 2014

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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).


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.
We found this trial at
1
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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