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

Early Phase 1

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Device: External Counterpulsation (EECP)

• Registration Number: NCT01659398
• Lead Sponsor: Patrick Moriarty, MD, FACP, FACC

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced external counterpulsation (EECP)	External Counterpulsation (EECP)	-

Primary Outcome Measures

Name	Time	Method
Change in Cognitive Function	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 Outcome Measures

Name	Time	Method
Cholesterol composition of the blood	Baseline to week 7
Change in Blood Viscosity	Baseline to Week 7
Change in Ophthalmic blood flow (OBF)	Baseline to Week 7

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States