Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077747
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-10-05
Brief Title:
Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Lumbar Vein Embolization for the Treatment of Chronic Headache in Patients With Nutcracker Physiology and Retrograde Lumbar Vein Flow With Epidural Venous Plexus Enhancement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic headaches in patients with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion All patients are extensively evaluated by a headache trained Neurologist confirming high pressure headache refractory to other treatments
Detailed Description:
This is a feasibility non-randomized non-blinded clinical trial enrolling patients who are at least 18 years of age for the treatment of chronic headache in the setting of Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus enhancement
Patients are initially evaluated by a fellowship trained headache neurologist to obtain a detailed headache history VAS score MIDAS score and physical examination They are also evaluated by a neuro ophthalmologist with fundoscopic examination to assess for disc edema A lab work-up is performed including complete blood count basic metabolic panel and microscopic urinalysis A lumbar puncture and imaging work-up are then obtained as well
Patients will proceed to an MRI to evaluate for Nutcracker physiology retrograde lumbar vein flow and epidural venous plexus enhancement if they meet the following criteria
1 Daily headache from onset lasting 3 months
2 Headache described as pressure sensation
3 Headache worsened in the Trendelenburg position
4 MRI MRA head and neck and MR venogram negative for possible secondary causes of headache including space occupying lesions Chiari malformation cerebral vein thrombosis hydrocephalus dissection aneurysm etc
a Transverse sinus stenosis is allowed to proceed
5 Exposed to CSF pressurevolume lowering medications
a Tried 2 of 4 unless contraindications acetazolamide methazolamide indomethacin SR or spironolactone or CSF volume removal via LP with positive or neutral response
6 Failed at least 3 typical headache preventative medications from different classes antidepressants antiepileptic and blood pressure If these criteria are met they will undergo an MRI to evaluate for Nutcracker physiology retrograde lumbar vein flow and epidural venous plexus enhancement For those patients that demonstrate Nutcracker physiology with retrograde lumbar vein flow and EVP enhancement they would be eligible for the clinical trial
If they are interested in the clinical trial they will be evaluated in clinic by a fellowship trained interventional radiologist to review the following
1 Procedural sedation moderate sedation versus general anesthesia
2 Prior contrast allergies
3 Consent for procedure
4 Prior to venography the patient is taken off all headache medications for 4 weeks
For patients that are still eligible and interested they will proceed with venography Venography involves an evaluation of the left renal vein and left lumbar vein to confirm the findings on the MRI If catheter-based venography confirms Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus enhancement they will then enter the clinical trial Embolization of the lumbar vein will be performed A follow-up venogram will then be performed to ensure there is no further retrograde lumbar vein flow
After the embolization patients will be followed for symptom evaluation at 13714 and 28 days after the procedure and then monthly They will also have a follow-up physical examination at 1 month 3 months 6 months and then every 6 months post-procedure They will be followed for a total of 18 months Some patients may need follow-up laboratory work-up and MRI post-procedure as standard of care
Patients are initially evaluated by a fellowship trained headache neurologist to obtain a detailed headache history VAS score MIDAS score and physical examination They are also evaluated by a neuro ophthalmologist with fundoscopic examination to assess for disc edema A lab work-up is performed including complete blood count basic metabolic panel and microscopic urinalysis A lumbar puncture and imaging work-up are then obtained as well
Patients will proceed to an MRI to evaluate for Nutcracker physiology retrograde lumbar vein flow and epidural venous plexus enhancement if they meet the following criteria
1 Daily headache from onset lasting 3 months
2 Headache described as pressure sensation
3 Headache worsened in the Trendelenburg position
4 MRI MRA head and neck and MR venogram negative for possible secondary causes of headache including space occupying lesions Chiari malformation cerebral vein thrombosis hydrocephalus dissection aneurysm etc
a Transverse sinus stenosis is allowed to proceed
5 Exposed to CSF pressurevolume lowering medications
a Tried 2 of 4 unless contraindications acetazolamide methazolamide indomethacin SR or spironolactone or CSF volume removal via LP with positive or neutral response
6 Failed at least 3 typical headache preventative medications from different classes antidepressants antiepileptic and blood pressure If these criteria are met they will undergo an MRI to evaluate for Nutcracker physiology retrograde lumbar vein flow and epidural venous plexus enhancement For those patients that demonstrate Nutcracker physiology with retrograde lumbar vein flow and EVP enhancement they would be eligible for the clinical trial
If they are interested in the clinical trial they will be evaluated in clinic by a fellowship trained interventional radiologist to review the following
1 Procedural sedation moderate sedation versus general anesthesia
2 Prior contrast allergies
3 Consent for procedure
4 Prior to venography the patient is taken off all headache medications for 4 weeks
For patients that are still eligible and interested they will proceed with venography Venography involves an evaluation of the left renal vein and left lumbar vein to confirm the findings on the MRI If catheter-based venography confirms Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus enhancement they will then enter the clinical trial Embolization of the lumbar vein will be performed A follow-up venogram will then be performed to ensure there is no further retrograde lumbar vein flow
After the embolization patients will be followed for symptom evaluation at 13714 and 28 days after the procedure and then monthly They will also have a follow-up physical examination at 1 month 3 months 6 months and then every 6 months post-procedure They will be followed for a total of 18 months Some patients may need follow-up laboratory work-up and MRI post-procedure as standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None