Clinical trial NCT06077747: Lumbar Vein Embolization for Chronic Headaches with Nutcracker Physiology
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Headache
Nutcracker Phenomenon, Renal
Nutcracker Syndrome, Renal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 pressure/volume 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 patient's will be followed for symptom evaluation at 1,3,7,14, 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.

Eligibility criteria: Inclusion Criteria:

* Daily headache from onset lasting \> 3 months.
* Headache described as pressure sensation.
* Headache worsened in the Trendelenburg position.
* Exposed to CSF pressure/volume lowering medications.
* Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response.
* Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications.
* MRI demonstrates that Nutcracker physiology is present.
* Decreased SMA angle, renal vein narrowing, decreased AMD.
* Retrograde lumbar vein flow and early EVP enhancement.
* Ability to understand study procedures and to comply with them for the entire length of the study.
* Negative pregnancy test.

Exclusion Criteria:

* Evidence of disc edema.
* Positive urinalysis for hematuria or proteinuria.
* Abnormal CBC or CMP.
* MRI, MRA head and neck and MR venogram with a possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc.

Primary outcomes:
measure: Change in headache pain
timeFrame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
measure: Change in Migraine Disability Assessment
timeFrame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
measure: Serious Adverse Events
timeFrame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Zlatko Devcic, MD
role: PRINCIPAL_INVESTIGATOR
References: