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

Patrick Moriarty, MD, FACP, FACC

Status and phase

Completed

Early Phase 1

Conditions

Mild Cognitive Impairment

Treatments

Device: External Counterpulsation (EECP)

Study type

Interventional

Funder types

Other

Identifiers

NCT01659398

13106

Details and patient eligibility

About

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).

Enrollment

8 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.