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

NCT ID: NCT01659398

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-10-31

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).

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced external counterpulsation (EECP)

Group Type: EXPERIMENTAL

External Counterpulsation (EECP)

Intervention Type: 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.

Subjects not receiving EECP

Control group to measure data from experimental group against.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patrick Moriarty, MD, FACP, FACC

OTHER

Sponsor Role: lead

Responsible Party

Patrick Moriarty, MD, FACP, FACC

Director, Clinical Pharmacology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Patrick Moriarty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

13106

Identifier Type: -

Identifier Source: org_study_id