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Completed

NCT Number: NCT02442856

Non-invasive Measurement of Cerebral Dynamic Autoregulation

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Thigh Cuff

Device

Primary outcomes

  1. dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD

    Time frame: 1.5 hours

    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.

  2. dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical

    Time frame: 1.5 hours

    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.

Other outcomes

  1. Linear Relationship Between Rate of Regulation Measured Using TCD and Optics

    Time frame: 1.5 hours

    Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: TOMCAT

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
May 13, 2015
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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