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

Study Overview
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Brief Summary
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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).

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: External Counterpulsation (EECP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced external counterpulsation (EECP)<br> | Device: External Counterpulsation (EECP)<br>* 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.<br>|
| No Intervention: Subjects not receiving EECP<br>Control group to measure data from experimental group against. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Function | 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). | Baseline, Week 7, 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ophthalmic blood flow (OBF) |  | Baseline to Week 7 | 
| Change in Blood Viscosity |  | Baseline to Week 7 | 
| Cholesterol composition of the blood |  | Baseline to week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, cerebral blood flow, ophthalmic blood flow, blood viscosity