Trial Outcomes & Findings for Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension (NCT NCT03041441)

Last Updated: 2020-07-28

Results Overview

The measurement of the momentary differences between the volumes of blood and CSF entering and leaving the cranium during the cardiac cycle provides an estimate of the intracranial volume change, and the pressure difference is estimated using the derivative of the CSF velocities.

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

During scan, approximately 30 minutes

Results posted on

2020-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	MRICP Method MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan. Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRICP Method n=5 Participants MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan. Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: During scan, approximately 30 minutes

Population: Data not collected on 4 participants.

Outcome measures

Outcome measures
Measure	MRICP Method n=1 Participants MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure. MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan. Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan
Intracranial Pressure Measurements Estimated by the MRICP Technique.	6.5 cm H20

PRIMARY outcome

Timeframe: During lumbar procedure, up to 2 hours

Population: Data not collected on 4 participants.

The CSF pressure measured at lumbar puncture (LP), is 100-180 mm of H2O (8-15 mm Hg) with the patient lying on the side and 200-300 mm with the patient sitting up.

Outcome measures

Outcome measures
Measure	MRICP Method n=1 Participants MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure. MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan. Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan
Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture	19.0 cm H20

SECONDARY outcome

Timeframe: Baseline, 24 hours

Population: Data not collected.

Description: assessment of change in estimated ICP prior to and following standard-of-care epidural patching; and (2) evaluate changes in diameter and flow velocity through the transverse dural venous sinus prior to and following epidural blood patching.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 hours

Population: Data not collected on 2 participants.

Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.

Outcome measures

Outcome measures
Measure	MRICP Method n=3 Participants MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure. MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan. Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan
Change in Caliber to the Transverse Venous Sinus Caliber	1.1 mm Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline, 24 hours

Population: Data not collected.

Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography

Outcome measures

Outcome data not reported

Adverse Events

MRICP Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Coordiantor

Duke University Dept of Radiology

Phone: (919) 684-7732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place