Status
Conditions
Treatments
About
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.
Full 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:
Daily headache from onset lasting > 3 months
Headache described as pressure sensation
Headache worsened in the Trendelenburg position
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
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
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:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
Loading...
Central trial contact
Julia Santos
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal