Saturday, May 5, 2018

Hope in China-- a new clinical trial

Over the past couple of years, I have been following a group of Chinese researchers from the Beijing Institute for Brain Disorders.   This group is using stents to repair slowed jugular venous flow, reduce collateral veins, improve intracranial hypertension and cerebral perfusion in a variety of patients.

My interest in this area comes from the fact that my husband was treated this same way in 2009.  His benefits from jugular stenting continue, as he has had no new white matter lesions.  He sleeps soundly, dreams, and wakes refreshed.  He had a huge reduction in headache.  His visual loss has ceased.  His fatigue has been reduced.  His gray matter atrophy has been reversed.  He has had no MS progression in eleven years.
Here is the publication on his treatment at Stanford
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164629/

The Beijing Institute for Brain Disorders was founded in 2012, in the hopes of using new technologies to prevent and repair neurological disorders.  The group of neurosurgeons have published  that jugular venous stenting is a safe and effective procedure, which is helping a variety of patients with neurological disorders.

They have seen intracranial hypertension, headache, visual disturbances, and tinnitus improved in 15 patients who had stents implanted in their jugular veins.
https://www.ncbi.nlm.nih.gov/pubmed/29114973

Because of their preliminary study, this group is now undertaking a randomized clinical trial in Beijng with 60 participants, utilizing stents in jugular veins of patients with jugular vein stenosis.  link to clinical trial

Here is what they will be looking at over the course of one year.  (Please notice how the secondary outcome measures are similar to measures used in Multiple Sclerosis clinical trials--and similar to my own husband's benefits from treatment.)

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Primary Outcome Measures  
Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins 
[Time Frame: baseline, 1, 6 and 12 months ]
The status of internal jugular vein blood flow and collateral veins will be evaluated by imaging modalities, mainly including: Jugular Vein Doppler Ultrasound, Magnetic Resonance Venography (MRV), Computed Tomography Venography (CTV) and Digital Subtraction Angiography (DSA)

Secondary Outcome Measures  :
The evaluation of cerebral spinal fluid (CSF) pressure 
[Time Frame: baseline, immediately post-stenting, within 1 month ]
CSF pressure will be assessed by lumbar puncture

The evaluation of headache 
[Time Frame: baseline, within 1, 6 and 12 months ]
The intensity of headache will be assessed with the Headache Impact Test-6 (HIT-6  The evaluation of tinnitus [ Time Frame: baseline, within 1, 6 and 12 months ]
The severity of tinnitus will be assessed by the Tinnitus Handicap Inventory Questionnaire (THIQ)

The evaluation of the severity of papilledema and other ophthalmological conditions 
[ Time Frame: baseline, within 1, 6 and 12 months ]
The severity of papilledema will be assessed based on Frisén papilledema grade (FPG) criteria; the assessment of other ophthalmological conditions including visual acuity, visual field, and fundus etc. will be based on visual acuity chart, visual fields picture, and optical coherence tomography (OCT) etc.

Changes in cerebral white matter (WM) 
[ Time Frame: baseline, within 12 months ]
The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).

The evaluation of cognitive function [ Time Frame: baseline, within 12 months ]
Cognitive function will be assessed with the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA) and/or the Modified Telephone Interview for Cognitive Status (TICS-M).

The evaluation of mental status [ Time Frame: baseline, within 12 months ]
Mental status will be assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS score ranges between 0 and 21 for either anxiety or depression. A cut-off point of 8/21 is indicated for anxiety or depression.

The evaluation of sleeping status [ Time Frame: baseline, within 12 months ]
Sleeping status will be assessed with the Pittsburgh Sleep Quality Index (PSQI) and/or the Athens Insomnia Scale (AIS). The PSQI score provides an overall score ranging from 0 to 21, where a cut-off score of ≤5 denotes a healthier sleep quality. The AIS score provides an overall score ranging from 0 to 24, where a cut-off score of <6 denotes a healthier sleep quality.

The extent of disability or dependence in the daily activities 
[ Time Frame: baseline, within 12 months ]
The extent of disability will be assessed by the modified Rankin Scale (mRS). (Score 0-no symptoms; score 1-no significant disability; score 2-slight disability; score 3-moderate disability; score 4-moderately severe disability; score 5-severe disability; score 6-dead.)

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Finally, here is a brand new published review from this same group, 
"Understanding jugular venous outflow disturbance."
link

I have read the full paper, and am confidant that this research group knows what they are doing, what they are looking for, and what the stakes are.  By removing Multiple Sclerosis from the equation, they will be able to proceed, without the interference of pharmaceutical interest--which has daunted the study of CCSVI.

Thanks to the Beijing Institute for Brain Disorders for taking on this very important study.

Joan