Non-invasive Measurement of Cerebral Dynamic Autoregulation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Thigh Cuff

• Registration Number: NCT02442856
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-13
• Study Start: 2015-06
• Primary Completion: 2019-03
• Results First Submitted: 2019-09-30
• Results First Submitted QC: 2019-11-14
• Results First Posted: 2019-12-03
• Study Completion: 2020-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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Exclusion Criteria

• Vascular risk factor subjects:

  1. Pregnant women
  2. Prisoners
  3. Prior neurosurgical procedure or traumatic brain injury, including hemicraniectomy or other skull defect
  4. Prior history of ischemic or hemorrhagic stroke
  5. Prior lower extremity amputation
  6. Peripheral vascular disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Thigh Cuff	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.

Primary Outcome Measures

Name	Time	Method
dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical	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.
dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD	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.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States