Non-invasive Measurement of Cerebral Dynamic Autoregulation

Stroke Clinical Trial

— TOMCAT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442856
• Other study ID #: 821705
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Thigh Cuff

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Linear Relationship Between Rate of Regulation Measured Using TCD and Optics	Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit	1.5 hours
Primary	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
Primary	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