[fmichael]

We are all too aware of the suffering of everyone who has exhausted every therapy and remains in intractable pain, or worse, so I've been looking to see what may be available on the short-to-medium-term horizon.

One of the things that the landmark study, Abnormal thalamocortical activity in patients with Complex Regional Pain Syndrome (CRPS) Type I, Walton KD, Dubois M, Llinás RR, Pain 2010 Jul; 150(1):41-51, Epub 2010 Mar 24, FULL ONLINE TEXT @ http://www.rsds.org/2/library/articl..._Pain_2010.pdf explained rather nicely was why and how it is that Deep Brain Stimulation (DBS) has been effective in CRPS. Unfortunately (or not in light of possible SERIOUS side effects) DBS for the treatment of pain was banned outside of experimental studies by the FDA in the mid-1980's. Nevertheless, it is approved from the treatment of dystonia and other movement disorders, there it is. And because it's approved for dystonia, etc., it can be done on an "off-label" basis: good luck getting insurance companies to pay for off-label neurosurgery!

Further, the same underlying mechanism, also explains for the first time why electro-shock from various sources actually works in CRPS, right down to the cellular level. For one of the many articles chronicalling the effectiveness of ECT, despite the fact that it's mechanism was "unknown," see, e.g., Treatment of CRPS with ECT, Wolanin MW, Gulevski V, Schwartzman R, Pain Phys. 2007;10:573-578 FULL ONLINE TEXT @ http://www.rsds.org/2/library/articl...chwartzman.pdf

But with ECT, the problem is that, even with the newer and safer "high dosage RUL ECT delivered with an ultra-brief stimulus" (The Cognitive Effects of Electroconvulsive Therapy in Community Settings, Sackeim HA, Prudic J, Fuller R, et al., Neuropsychopharmacology 2007; 32:244-254), the fact remains that there is no money to pay for the large scale studies necessary to obtain FDA approval of RUL ECT for CRPS. Quite simply because, to the medical device industry, having a few thousand CRPS patients using its ECT equipment would be a drop in the bucket, not worthy of investing in new studies. And as a result, without a "co-morbid" Dx of otherwise untreatable depression, insurance carriers won't pick that one up either.

I am however pleased to announce that a new contender has entered the building, if not the arena:

Motor cortex electrical stimulation applied to patients with complex regional pain syndrome, Velasco F, Carrillo-Ruiz JD, Castro G, Argüelles C, Velasco AL, Kassian A, Guevara U, Pain. 2009 Dec 15;147(1-3):91-8, Epub 2009 Sep 29, FULL ONLINE TEXT @ http://www.rsds.org/2/library/articl...uiz_Castro.pdf

Unit for Stereotactic, Functional Neurosurgery and Radiosurgery of the Service of Neurology and Neurosurgery and Pain Clinic, General Hospital of Mexico, Mexico City, Mexico. slanfe@prodigy.net.mx

Abstract
Motor cortex stimulation (MCS) is useful to treat patients with neuropathic pain syndromes, unresponsive to medical treatment. Complex regional pain syndrome (CRPS) is a segmentary disease treated successfully by spinal cord stimulation (SCS). However, CRPS often affects large body segments difficult to cover by SCS. This study analyzed the MCS efficacy in patients with CRPS affecting them. Five patients with CRPS of different etiologies underwent a small craniotomy for unilateral 20-grid-contact implantation on MC, guided by craniometric landmarks. Neurophysiological and clinical tests were performed to identify the contacts position and the best analgesic responses to MCS. The grid was replaced by a definitive 4-contacts-electrode connected to an internalized system. Pain was evaluated by international scales. Changes in sympathetic symptoms, including temperature, perspiration, color and swelling were evaluated. Pre-operative and post-operative monthly evaluations were performed during one year. A double-blind maneuver was introduced assigning two groups. One had stimulators turned OFF from day 30-60 and the other from day 60-90. Four patients showed important decrease in pain, sensory and sympathetic changes during the therapeutic trial, while one patient did not have any improvement and was rejected for implantation. VAS and McGill pain scales diminished significantly (p<0.01) throughout the follow-up, accompanied by disappearance of the sensory (allodynea and hyperalgesia) and sympathetic signs. MCS is effective not only to treat pain, but also improve the sympathetic changes in CPRS. Mechanism of action is actually unclear, but seems to involve sensory input at the level of the spinal cord.

PMID: 19793621 [PubMed - indexed for MEDLINE] [Emphasis added: the point is huge!]

http://www.ncbi.nlm.nih.gov/pubmed/19793621 (And note how they can do double blinding simply by turning electrodes off and on, which is a neat trick.)

Finally, for a nice article explaining both MCS and DBS in clear language, check out, Intracranial Neurostimulation for Pain Control: A Review, Robert Levy, Timothy R. Deer and Jaimie Henderson, Pain Physician 2010; 13:157-165, FULL ONLINE TEXT @ http://www.painphysicianjournal.com/...13;157-165.pdf (And for any unknown term, just Google/bing/yahoo the word in question, preceded by "definition.")

That said, it's too bad that Levy et al missed the 2009 article from Velasco et al, when they go on to say:

While many case series have been published on the use of MCS or DBS for pain, no randomized, controlled trials exist to confirm the therapies’ effectiveness. This lack of class I data may cause some observers to view the therapies skeptically in spite of their considerable history of clinical use. MCS is probably better suited to such studies than other forms of neurostimulation, in that effective stimulation evokes no perception on the part of the patient save for pain relief. This presents researchers with a unique opportunity to perform blinded studies in which placebo effects can be assessed. Such studies could employ crossover designs to encourage enrollment and address ethical concerns related to the implantation of leads into control patients.

The lack of randomized controlled trials may be due, in part, to the challenges of patient recruitment and monitoring and the need to assign patients to control groups, which by definition means subjecting patients to treatments that have already been unsuccessful in managing their pain. However, the risk of not performing these studies is great, because it means that both physicians and patients lack definitive information about the efficacy of intracranial neurostimulation therapies. This then will slow the further development of the therapies and limit the access of patients to them in the future.

Little did they know that, in the case of MCS, it was simply a matter of flipping the switches every so often!

Hopefully, industry has now gotten the message and large scale studies (if performed in only a few select locations) will soon be underway.

Mike

[Boilermakers38]

Hello, My name is Mike. My Pain Mangement Doctor has suggested that I consider Neurostimulation Theraphy and have the device surgically implanted. I have been dealing with low back pain traveling through my left leg. I have this pain 24/7 and at times is very difficult to even preform my ADL's. I have been taking pain pills like Morphine for 3 years, done the physical therapy, injections and still live in this pain.

Does someone have any information you would share with me regarding your experience.

Thank you in advance for your time.

Mike

[fmichael]

Originally Posted by Boilermakers38

Hello, My name is Mike. My Pain Mangement Doctor has suggested that I consider Neurostimulation Theraphy and have the device surgically implanted. I have been dealing with low back pain traveling through my left leg. I have this pain 24/7 and at times is very difficult to even preform my ADL's. I have been taking pain pills like Morphine for 3 years, done the physical therapy, injections and still live in this pain.

Does someone have any information you would share with me regarding your experience.

Thank you in advance for your time.

Mike

Dear Mike -

Hi there. First, I should say that I've never been offered a SCS because it was thought the pain was too diffuse in my body, where both legs were often in almost total spasm and I had bilateral CRPS in both feet and ankles following an injury at the gym.

Two quick points.First, Neurotalk maintains a "sub-forum" on SCS & Pumps at http://neurotalk.psychcentral.com/forum118.html that I would urge you to check out.

Secondly, I have just come across an article stating that while SCS may provide pain relief from anywhere from 2 - 20 years, it will not otherwise stop the progress of the disease. AAPM: Spine Stimulation Leads to Durable Pain Relief, February 07, 2010, reporting on presentation of Krishna Kumar, MB, BS, of Regina Qu'appelle Health Region in Regina, Saskatchewan, said at the American Academy of Pain Medicine meeting. "All patients in this series experienced a gradual enlargement in the area affected over time. Stimulation does not appear to retard disease spread."

http://www.medpagetoday.com/tbprint.cfm?tbid=18344

Mike

[debbiehub]

thanks for the article Mike...How do I sign up??

Debbie

[ballerina]

Hi all, I have been lurking for about a year and must now post to share the success of a deep brain stimulation treatment that I recently had. Writing is extremely difficult for me due to cognitive impairment by CRPS so please bear with me. After the frustration of one more physician suggesting I see a psychiatrist for what I, through my own research knew was autonomic and limbic dysfunction directly related to CRPS, I did what I have done for two years, my own research to help myself. Since I am already doing mirror therapy and graded motor imagery to address cortical reorganization, I began looking at ECT and related treatments. I came upon a clinical trial on tCDS (transcranial Cortical Deep Stimulation. Since I was too late to join the clinical trial I requested to receive the treatment on an outpatient basis. I went to Beth Israel in New Your City the first week in February and received the treatment for five days. The down side is that my health insurance did not cover it because it is experimental). The up side is that I had a dramatic positive response to the treatment: Increased mental clarity, decrease in daily pain range from 5 to 8 out of ten to 2 to 6 out of ten, increased range of motion, improvement in balance and coordination, decrease in ice cold limb, elimination of tremors, bladder problems returned to normal and many more subtle improvements. This treatment is non-invasive, painless and there are only minimal side effects (fatique, headache) which quickly vanish after treatment. There are no long term side effects and the treatment may be repeated indefinitely. I was cautioned that this treatment, like ketamine and blocks, wears off over time. I jokingly told Drs. Knotkova and Cruciani that I should get a 9 volt battery, some electrodes, sponges and saline solution and treat myself. My plan now is to either convince my PM physician to become trained and offer the treatment in his practice (in my dreams) or purchase the equipment and treat myself. The Research conducted by Dr Helena Knotkova and Dr. Ricardo Cruciani is due to be published in March. When I asked how soon this treatment would be routinely available to patients I was told 5-10 years. That's not good enough for me.

Getting very tired so I must go. Will post other non traditional and experimental treatments that have greatly help me. Many thanks to the useful info I have received from this community. I feel like I already know mike and greatly miss the input of Vic who is deceased. Hope this helps!!!!!

[fmichael]

Dear Debbie -

Looks like we missed the boat, at least for now. Running a search through ClinicalTrials.gov - maintained by the NIH at http://www.clinicaltrials.gov/ct2/home - as well as the WHO's International Clinical Trials Registry Platform (ICTRP) http://www.who.int/ictrp/en/ shows only a single study on point The Efficacy of Motor Cortex Stimulation for Pain Control, under the direction of Robert M. Brownstone, MD, PhD, a neurosurgeon at the Neuroscience Institute, Dalhousie University, Halifax, Nova Scotia, who has some 38 highly sophisticated neuroscience and neurosurgery articles coming up on PubMed, many of which are freely downloadable. And that study apparently completed its final data collection in July, 2010. So publication is hopefully imminent.

And the "Detailed Description" of the study is encouraging:

This is a prospective, blinded randomized crossover study comparing two stimulation paradigms in three different groups of patients receiving motor cortex stimulation. The aim of this study is to examine the effectiveness of this modality in a controlled blinded manner, which has not been done in previous studies. There are two primary purposes of this study. The first is to compare two different stimulation paradigms: "high" level stimulation (i.e. stimulator activated 'on' for 10 minutes, 'off' for 2 hours; presumed therapeutic dose); versus "low" stimulation ('on' for 1 minute, 'off' for 6 hours; presumed subtherapeutic dose), in a prospective blinded crossover study design.

The second purpose of this study, is to examine the outcome of MCS in three different pain groups. These are:

1. Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain
2. Neuropathic deafferentation facial pain
3. Upper extremity complex regional pain syndrome (CRPS)

Measurements of the effects of motor cortex stimulation will include a visual analogue scale (VAS) of perceived pain, the McGill Pain Questionnaire, SF-36 quality of life questionnaire, Beck Depression Inventory-II, the standard 7-point patient global impression of change (PGIC), medications log (verified by pharmacy records) and an employment status questionnaire. Adverse events will be recorded at each visit. . . . [Emphasis added.]

http://www.clinicaltrials.gov/ct2/sh...0462566&rank=1

http://www.nhs.uk/Conditions/Complex...n=5&Rec=0&CT=0

I suppose what really gets my attention is that researchers are now calibrating dosages!

Mike

[debbiehub]

I see one criteria was upper extremity RSD- mine started as lower and not body wide..

[fmichael]

Originally Posted by debbiehub

I see one criteria was upper extremity RSD- mine started as lower and not body wide..

Debbie -

Not to worry, they were doing a study with a combination of TOS patients.

Trust me, the CRPS results - if statistically robust - will be FULLY GENERALIZABLE: the only difference being in where the electrodes are placed following an fMRI.

Mike

[fmichael]

Originally Posted by ballerina

Hi all, I have been lurking for about a year and must now post to share the success of a deep brain stimulation treatment that I recently had. Writing is extremely difficult for me due to cognitive impairment by CRPS so please bear with me. After the frustration of one more physician suggesting I see a psychiatrist for what I, through my own research knew was autonomic and limbic dysfunction directly related to CRPS, I did what I have done for two years, my own research to help myself. Since I am already doing mirror therapy and graded motor imagery to address cortical reorganization, I began looking at ECT and related treatments. I came upon a clinical trial on tCDS (transcranial Cortical Deep Stimulation. Since I was too late to join the clinical trial I requested to receive the treatment on an outpatient basis. I went to Beth Israel in New Your City the first week in February and received the treatment for five days. The down side is that my health insurance did not cover it because it is experimental). The up side is that I had a dramatic positive response to the treatment: Increased mental clarity, decrease in daily pain range from 5 to 8 out of ten to 2 to 6 out of ten, increased range of motion, improvement in balance and coordination, decrease in ice cold limb, elimination of tremors, bladder problems returned to normal and many more subtle improvements. This treatment is non-invasive, painless and there are only minimal side effects (fatique, headache) which quickly vanish after treatment. There are no long term side effects and the treatment may be repeated indefinitely. I was cautioned that this treatment, like ketamine and blocks, wears off over time. I jokingly told Drs. Knotkova and Cruciani that I should get a 9 volt battery, some electrodes, sponges and saline solution and treat myself. My plan now is to either convince my PM physician to become trained and offer the treatment in his practice (in my dreams) or purchase the equipment and treat myself. The Research conducted by Dr Helena Knotkova and Dr. Ricardo Cruciani is due to be published in March. When I asked how soon this treatment would be routinely available to patients I was told 5-10 years. That's not good enough for me.

Getting very tired so I must go. Will post other non traditional and experimental treatments that have greatly help me. Many thanks to the useful info I have received from this community. I feel like I already know mike and greatly miss the input of Vic who is deceased. Hope this helps!!!!!

Dear Ballerina -

My goodness, you have been hanging around for a while! So how far back do we do go, as in, does the name John Lester mean anything to you? In any event, we are honored by your (re?)emergence.

You raise the matter of cognitive impairment by CRPS. In that spirit please forgive me for having literally overlooked your post Monday afternoon. I swear, I didn't see it earlier, which is too bad because it is a very small world. In late 2007, I was working on an article on the use of RUL ECT for CRPS when Jim Broach suggested that I speak to Dr. Knotkova about her work on tCDS. She was very kind and provided me with some articles on the subject - please see the attached - but to which I made only passing reference in my piece, which Jim was kind enough to arrange to have published. Right Unilateral Electroconvulsive Therapy Treatment for CRPS, Michaels F Jr., Pract Pain Manage. 2008 March, ONLINE TEXT @ http://www.rsds.org/2/library/articl...haels_CRPS.pdf

Smaller world still, over the last few months I’ve been trying to get an fMRI to fully access the neurocognitive hit of nearly 10 years of CRPS, which I perceive as an almost complete loss of executive functioning - on top of preexisting "pure" ADD - and a lot of short term and working memory loss. See, Neuropsychological deficits associated with Complex Regional Pain Syndrome, Libon DJ, Schwartzman RJ, Eppig J, et al, J Int Neuropsychol Soc. 2010 May;16(3):566-73, Epub 2010 Mar 19, ONLINE TEXT @ http://www.rsds.org/2/library/articl...ychol_2010.pdf So, my doctor suggested a radiology practice affiliated with a local neurologist who is now using a T-3 fMRI to calibrate his rTMS treatments: repetitive transcranial magnetic stimulation. http://en.wikipedia.org/wiki/Transcr...ic_stimulation Unfortunately, because their fMRI “protocols” were designed to locate only areas of pain activity, as opposed to cognition, the radiology practice told me that it would be unable to perform any functional analysis of cognition. And where they claimed only that 60% of those undertaking the (experimental and uninsurable, except for depression) rTMS treatments received a 50% reduction in pain lasting approximately 14 months, I took a pass where I had once been quoted better odds on a 5 – day Lidocaine infusion that did nothing for me. And note that, at least, based upon the attached correspondence to the British Journal of Psychiatry from Fregni et al (2005), TMS is significantly more expensive than tCDS.

I have no idea whether the rTMS would have had cognitive effects, where the magnetic force would have been precisely “aimed” only at those cortical areas associated with pain. Maybe I made the wrong call. As it is, I’m attempting to have the fMRI set up at UCLA instead.

And of course, I’m thrilled by your report, as well as knowing that after at least five years of effort, Drs. Knotkova and Cruciani’s work will be published next month. That’s really great, especially with the promise of affordable care in tCDS. Good times!

It’s funny, I’ve gotten more mileage out of some recent “stretching” PT with an emphasis on “nerve gliding” than anything else I can recall in the last few years. [If anyone in LA wants a reference, drop me a PM.] Sometimes it’s the subtle tweak that makes all the difference. And as interesting as it to speculate that one day we will be able to harness the Large Halcyon Collider in the pursuit of the ultimate mysteries of CRPS, it is so much more comforting when something on a human scale can make all the difference. (Suddenly, I am reminded of watching Nureyev from a distant balcony, thirty years ago and then past his prime, holding the hall spellbound with a perfect turn of his ankle.)

Mike

[ballerina]

Hi Mike,
Small world indeed! I have had CRPS since a fall while teaching classical dance in November 2008. My horror stories regarding delayed diagnosis and treatment mirror those of others in this community, thus need no further comment.

Most everything that has been helpful to me is the result of my own research and includes reviewing all past RSD/CRPS posts on Neurotalk. I am so sorry you struggle with cognitive problems and I was saddened to learn through your earlier posts that your long battle with CPS forced you to give up what had to have been your passion, being an attorney.

My success with tCDS was quite encouraging to me since the treatment improved my short term memory problems, word finding problems and sequential processing problems. Although I have a doctorate is is extremely difficult to organize my thoughts and write. Like you, I also have a preexisting brain dysfunction, severe dyslexia. It took me an hour just to register on this site and my first post was lost and I couldn't figure out how.

I learned through my own efforts that my new cognitive problems were not the result of a psychiatric problem as had been suggested by numerous physicians. Thanks for the article by Libon et. al. Prior to my tCDS treatment I tried to get a form of magnetic brain stimulation offered locally (Maryland) through a psychiatrist. I was rejected, however, because I do not have clinical depression. The good news about tCDS is that it seems to be effective for folks with intractable long standing CRPS. Additionally it does not carry the rTMS risk for seizure.

For me, the loss of executive function has been every bit as bad as the pain and other symptoms. I took a chance given the odds of success for me was about 70% and I am convinced that cortical reorganization is the key for me. I expect this will wear off in a month to 9 months. I am using this time to push the limits in PT. I am having good results with mirror therapy and graded motor imagery as well as exercises for stretching and balance.

Who is John Lester? That name does not ring a bell but neither do many names from the past two years.