Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Coil Embolization of the Lumbar Vein
Procedure/SurgeryCatheter based venography will first confirm Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus congestion. The lumbar vein will then be coil embolized.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Coil embolization of lumbar veinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in headache pain
Measured by a visual analogue scale (VAS) where 0 = no pain, 5= moderate pain, 10= worst pain
Time frame
1,3,7,14, and 28 days after the procedure and then monthly for 17 months2
Change in Migraine Disability Assessment
Measured by the Migraine Disability Assessment Test
Time frame
1,3,7,14, and 28 days after the procedure and then monthly for 17 monthsSecondary outcomes
1
Adverse Events
Number of adverse events defined as any unwanted symptom that occurred from embolizing the lumbar vein such as flank pain, proteinuria, hematuria, or pelvic congestion.
Time frame
1,3,7,14, and 28 days after the procedure and then monthly for 17 months2
Serious Adverse Events
Number of serious adverse events defined as any serious unexpected complication during or after the embolization that would result in death, is life threatening, requires prolonged hospitalization, causes persistent or significant disability or incapacity, or another condition that represents significant hazards.
Time frame
1,3,7,14, and 28 days after the procedure and then monthly for 17 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov