StrokeTOMCATNCT02442856

Non-invasive Measurement of Cerebral Dynamic Autoregulation

A study testing Thigh Cuff in people with Stroke, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Stroke
What is being tested?: Thigh Cuff
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Jun 2015to Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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
Being tested: Thigh Cuff
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thigh CuffDevice

Study groups in NCT02442856
Study group	Role	What they receive
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. Receives: Device: Thigh Cuff

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 1.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Mar 2020

First posted13 May 2015 (estimated)
Study startJun 2015
Primary completionMar 2019
Study completionMar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02442856
Sponsor's protocol ID: 821705
Acronym: TOMCAT
Status last verified: Aug 2020
First submitted: 8 May 2015
Last updated: 14 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Measurement of Cerebral Dynamic Autoregulation
ClinicalTrials.gov ID: NCT02442856
Acronym / sponsor ID: TOMCAT / 821705
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: Jun 2015 (actual)
Primary completion: Mar 2019 (actual)
Study completion: Mar 2020 (actual)
First posted: 13 May 2015 (estimated)
Results: Posted 3 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Device: Thigh CuffWe 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

Vascular risk factor subjects:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thigh Cuff	Device	Intervention

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 3 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	21	21

Primary outcome: dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD

Time frame: 1.5 hours. Number (95% Confidence Interval). Unit: per second

Measure	Intervention n = 11
Value	0.262 (0.170 to 0.366)

Population analysed: 21 subjects consented, hemodynamic monitoring possible in 18. 1 subject did not tolerate,data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate cerebral blood flow(CBF) was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis

Primary outcome: dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical

Time frame: 1.5 hours. Number (95% Confidence Interval). Unit: per second

Measure	Intervention n = 11
Value	0.278 (0.199 to 0.300)

Population analysed: 21 subjects in the study, but hemodynamic monitoring was only possible in 18. 1 subject did not tolerate, and data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate CBF was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis

Adverse events

Time frame: Duration of study, which was approximately 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Thigh Cuff in people with Stroke, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD (time frame: 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02442856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.