Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Miami | OTHER |
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRICP method | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI algorithm | Device | MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During scan, approximately 30 minutes |
| 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. | During lumbar procedure, up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Kranz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data not collected on 4 participants. | Posted | Number | cm H20 | During scan, approximately 30 minutes |
|
up to 30 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRICP Method | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordiantor | Duke University Dept of Radiology | (919) 684-7732 | christopher.vallanat@duke.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2019 | Jul 9, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019585 | Intracranial Hypotension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lumbar puncture | Procedure | Lumbar puncture according to the standard-of-care treatment plan. |
|
| Epidural patching | Procedure | Epidural patching will be performed to the standard-of -care treatment plan |
|
| 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. |
| Baseline, 24 hours |
| 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 | Baseline, 24 hours |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Data not collected on 4 participants. | Posted | Number | cm H20 | During lumbar procedure, up to 2 hours |
|
|
|
| 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. | Data not collected. | Posted | Baseline, 24 hours |
|
|
| 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. | Data not collected on 2 participants. | Posted | Mean | Standard Deviation | mm | Baseline, 24 hours |
|
|
|
| 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 | Data not collected. | Posted | Baseline, 24 hours |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
Not provided
Not provided
Not provided
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |