Intracranial Hypotension
Conditions
Brief summary
The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI) techniques, and to determine whether changes in estimated ICP are seen after treatment of this condition.
Detailed description
Subjects with known intracranial hypotension who are scheduled to undergo standard-of-care CSF pressure measurement using lumbar puncture prior to planned epidural patch treatment will first undergo a research MRI of the brain in order to estimate ICP. The imaging protocol is listed in Appendix 1. All research scans are performed without intravenous contrast. Approximate scan time per session will be 20-22 minutes. Subjects will then undergo lumbar puncture according to the standard-of-care treatment plan. Estimated values of CSF pressure derived from MRI will be compared to values measured during lumbar puncture. Patients will then undergo standard-of-care epidural patching. A repeat research MRI after epidural patching will be performed to assess for differences in pre- and post-treatment scans.
Interventions
DEVICEMRI algorithm
MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion
PROCEDURELumbar puncture
Lumbar puncture according to the standard-of-care treatment plan.
PROCEDUREEpidural patching
Epidural patching will be performed to the standard-of -care treatment plan
Sponsors
University of Miami
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Known diagnosis of intracranial hypotension, established by the following criteria: the presence of orthostatic headache, and one or more of the following criteria: prior CSF opening pressure ≤6 cmH20, demonstration of an active spinal CSF leak on prior spine imaging, or cranial MRI changes of intracranial hypotension.15 * Ability to provide informed consent. * Expected ability to complete standard-of-care procedures (lumbar puncture and epidural patching)
Exclusion criteria
* Known contraindication to MRI (pacemaker, MRI incompatible hardware, etc.) * Severe claustrophobia or other condition requiring the need for anxiolysis, sedation, or any other medication for MRI scanning * Inability or expected inability to complete study interventions as scheduled * Any known contraindication to standard-of-care procedures (e.g. coagulopathy, allergic reaction to required medication, lack of vascular access, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial Pressure Measurements Estimated by the MRICP Technique. | During scan, approximately 30 minutes | 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. |
| Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture | During lumbar procedure, up to 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intracranial Pressure Estimated With MR Technique | Baseline, 24 hours | 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. |
| Change in Caliber to the Transverse Venous Sinus Caliber | Baseline, 24 hours | Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography. |
| Change in Flow Velocity Through the Transverse Dural Venous Sinus | Baseline, 24 hours | Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | MRICP Method |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture
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.
Time frame: During lumbar procedure, up to 2 hours
Population: Data not collected on 4 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRICP Method | Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture | 19.0 cm H20 |
Primary
Intracranial Pressure Measurements Estimated by the MRICP Technique.
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.
Time frame: During scan, approximately 30 minutes
Population: Data not collected on 4 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRICP Method | Intracranial Pressure Measurements Estimated by the MRICP Technique. | 6.5 cm H20 |
Secondary
Change in Caliber to the Transverse Venous Sinus Caliber
Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.
Time frame: Baseline, 24 hours
Population: Data not collected on 2 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MRICP Method | Change in Caliber to the Transverse Venous Sinus Caliber | 1.1 mm | Standard Deviation 0.5 |
Secondary
Change in Flow Velocity Through the Transverse Dural Venous Sinus
Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography
Time frame: Baseline, 24 hours
Population: Data not collected.
Secondary
Change in Intracranial Pressure Estimated With MR Technique
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.
Time frame: Baseline, 24 hours
Population: Data not collected.