Non-invasive Measurement of Cerebral Dynamic Autoregulation

NCT02442856 | Completed Results

• 1 other identifier: 821705
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to evaluate the use of diffuse correlation spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with vascular risk factors. Optical cerebral blood flow measurements will be correlated with changes in arterial blood pressure to assess how CBF is maintained in response to changes in ABP, and will be compared to transcranial doppler reference measurements.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD

  Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.

  1.5 hours

• dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical

  Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.

  1.5 hours

Other Outcomes (1)

• Linear Relationship Between Rate of Regulation Measured Using TCD and Optics

  1.5 hours

Study Arms (1)

Intervention

EXPERIMENTAL

We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.

Device: Thigh Cuff

Interventions

Thigh Cuff DEVICE

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 50 years
• Positive history of at least one of the following vascular disk factors: hypertension, diabetes, hyperlipidemia, coronary artery disease, atrial fibrillation, prior myocardial infarct, transient ischemic attack, or history of smoking

You may not qualify if:

• Vascular risk factor subjects:
• Pregnant women
• Prisoners
• Prior neurosurgical procedure or traumatic brain injury, including hemicraniectomy or other skull defect
• Prior history of ischemic or hemorrhagic stroke
• Prior lower extremity amputation
• Peripheral vascular disease

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Michael Mullen
• Organization: University of Pennsylvania

mmullen@pennmedicine.upenn.edu

215-662-3339

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 13, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 14, 2020
• Results First Posted: December 3, 2019

Record last verified: 2020-08

Locations

US (1)