Study of Deep Brain Stimulation for Chronic Pain Shows Some Promise

Study of Deep Brain Stimulation for Chronic Pain Shows Some Promise

By Staff.

Neuromodulation has been used to successfully treat many chronic pain sufferers through the delivery of electrical stimulation to the spinal cord.  The electrical current disrupts the pain signal before it reaches the brain.

Now researchers are advancing another type of neuromodulation to treat pain, called Deep Brain Stimulation (DBS), which has been used to quell the electrical storms in the brains of Parkinson’s sufferers, and for other disorders.

Researchers at the Cleveland Clinic have published data on the first prospective, randomized, controlled trial of DBS for neuropathic pain.  The scientists used deep brain stimulation (DBS) of the ventral striatum/anterior limb of the internal capsule is safe and feasible in addressing the affective component of pain in patients with post-stroke pain syndrome.

“We showed that active versus sham DBS of the ventral striatum/anterior limb of the internal capsule produced significant improvements in multiple outcome measures associated with the affective sphere of chronic pain,” said lead investigator Andre Machado, MD, PhD, Chairman of Cleveland Clinic’s Neurological Institute. “This trial represents a paradigm shift in chronic pain management in that it targeted neurostimulation to brain structures related to the affective, rather than sensory, sphere of chronic pain.”

Previous studies of DBS and other forms of neuromodulation for pain have focused nearly exclusively on modulation of pain transmission and pain amplitude, Dr. Machado noted.

“In this study, we departed from an analgesia-based approach and focused on neural networks related to control of emotion and behavior based on our hypothesis that modulating the affective sphere of pain would improve quality of life or relieve pain-related disability, with or without attenuation of pain intensity,” he described.

To test that hypothesis, the researchers designed their investigator-initiated study as a six-month, randomized, double-blind, placebo-controlled, crossover trial.

They enrolled 10 Cleveland Clinic patients with longstanding post-stroke pain syndrome who had hemibody pain and anesthesia dolorosa secondary to a contralateral lesion.

“We chose post-stroke pain syndrome because it is associated with severe, refractory pain and patients with this syndrome are in need of therapies to alleviate suffering and disability,” said Dr. Machado. “Because these patients have complete or near-complete damage to the sensory-discriminative pathways, they also provided a unique model for studying the effects of neuromodulation specifically on brain networks related to emotion and behavior control.”

All patients underwent bilateral implantation of electrode array leads through the anterior limb of the internal capsule (ALIC) into the ventral striatum (VS). Surgical targeting was based on the investigators’ experience with DBS for obsessive-compulsive disorder (OCD) and treatment-resistant depression. “We targeted the VS/ALIC because of its well-established role in controlling emotion and behavior and the documented safety of DBS in this brain region for treating OCD and treatment-resistant depression,” said Dr. Machado.

One month after implantation, patients were randomized to active DBS or sham for three months and then crossed over to the other arm for another three months. After this blinded phase, patients underwent an 18-month open stimulation phase.

The study was negative for its primary and secondary end point, with no significant difference seen in pain-related disability on the PDI between active and sham treatment during the blinded stimulation phase.

They did, however, find significant differences in favor of active DBS in multiple outcomes associated with the affective dimension of chronic pain.

“Although the primary end point was not achieved, the efficacy of DBS was manifested by significant improvements in indices of the affective component of pain, such as depression, anxiety and quality of life,” Dr. Machado observes. “These improvements — achieved without significant reductions in the amplitude of pain — corroborate our hypothesis and suggest that DBS of the VS/ALIC specifically modulated the affective sphere of pain in patients with post-stroke pain syndrome.”

The findings suggest that analgesia may not be the appropriate treatment goal in central pain syndromes, said Dr. Machado. “We contend that neuromodulation therapies should focus on reducing pain-related suffering or disability rather than pain intensity,” he says. “We propose a shift in surgical targeting away from neural networks underlying the sensory-discriminative domain toward the networks that mediate the affective-motivational sphere of chronic pain.”

He adds that his team’s future work will involve analyzing functional neuroimaging and neurophysiological data obtained during this study to develop objective biomarkers that could help improve patient selection. These data will also be used to examine the neural substrates underlying how DBS impacts the affective aspect of pain.

The team also plans to initiate a multicenter study to confirm these findings elsewhere and potentially expand the study population to include patients with other types of chronic pain. “We believe the present findings justify further investigation of this treatment approach,” said Dr. Machado.

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Authored by: Staff

There are 10 comments for this article
  1. Michael Wilson at 6:42 am

    I’ve lived with intractable chronic pain for over thirty years! I have Adhesive Arachnoiditis for which the only successful treatment has been opioids prescribed by my pain management MD! I tried every treatment suggested including the Spinal Stimulator, wich was a colossal failure. The antenna implanted in my spine, intended to send a signal to my brain, got loose and migrated two inches up and into my spine. It took me almost six months to convince the doctors at Johns Hopkins that my pain was real! I think they didn’t want to have a negative impact on their study! I know I took the long way around but, when it comes to these studies the authors are totally biased! When it comes to my pain…I’ve had thirty years of research under my belt. With some of the top Specialists in the area. I trust in what I’ve learned and what I feel. I wonder why no one ever asks for my opinion?

  2. Bob Schubring at 1:41 pm

    There now exists a technology called Positron Emission Tomography, or PET.

    A PET scan of a patient’s brain, examining the region of the Periaqueductal Grey Matter, proves the existence of chronic pain.

    The test costs about $5,000 US dollars.

    It would be reasonable to require any person, who alleges that our pain isn’t real, and seeks control of what we patients are allowed to do for our pain or limit what doctors and Good Samaritans might do for our pain, be forced to first fork over the five grand and pay for a PET scan of our brains, out of his own greedy mitts, to test his allegations against us before he repeats them again.

    After he’s blown fifteen grand, alleging that three chronic pain patients are making it all up, and he feels a little bit poor, the bigmouth will probably shut up and accept the fact that our pain is real.

    Free Speech is a right not to pay the Government a fee, for a license to talk to people. It’s not an absolute right to advocate harming others.

    Those who advocate harming pain patients, or imposing a Hillary Clinton-Joe Manchin-Charles Schumer-style tax on our medicines, are advocating harm against us. That advocacy of harm, is not Free Speech as protected by law.

    Let’s demand that the dirty rotten buggers put real money out of their own pockets, into proving their goofball theories about us, before our lives are tampered with at all.

  3. Allison Novak at 1:37 pm

    I agree with Kathy C’s, Ibin’s, and HJ’s comments. All well articulated.

    To add my two cents worth: I was diagnosed with Major Depressive Disorder 3 decades ago. Ten ECT (Electro-Convulsive Therapy, better known as “Shock Therapy”) treatments were administered to me. Absolutely not beneficial for me, and I barely had a headache​ upon waking, which I was told was rare. The doctors told me, “We’re not sure why it works, but it seems to help.”

    This new experimental therapy strikes me as potentially dangerous and barbaric at best. I think about when the Mayans conducted ‘brain surgery’.

    If the whopping 10 subjects articulated less pain emotionally or verbally – “affective”… Must work, right????? Reminds me of how frontal lobotomy patients were less emotionally expressive… “affective”.

    I’ve read time and time again that under-treated chronic pain affects the portion of our brains that regulates emotive control. So if emotive control becomes a flattened dull affect… Must mean the treatment works, right? I think not.

    Excuse me while I take another dose of Kratom…because opiates are no longer available to me…because I smoke marijuana in a state where recreational and medical marijuana is legal. Never mind that the CDC very quietly released a statement buried in a 40-page document advising clinicians to stop testing for THC, under the concern that patients would be harmed if they were rejected for chronic pain treatment due to marijuana use. Never mind that opiate use drops by 25% in the states where marijuana is legal. The pain clinic arbitrarily determined that marijuana is “illegal” and I am not welcome there as a patient.

    I am disgusted. Healthcare has become an oxymoron and the “practice” of medicine has become barbaric.

  4. Chris at 11:42 am

    I currently have a deep brain stimulator and motor cortex stimulator for chronic post-stroke pain. I was not part of this study, but I can tell you that it has been a life saver for me. I had a freak stroke at the age of 27. I recovered completely from the stroke in all other ways except for debilitating pain. At the age of 31, after trying over 25 medications, injections, and Eastern medicine, I received my stimulators at Vanderbilt University. They work and I now completely medication free. I am so grateful that I don’t have to live a life full of pain and addicted to opiates.

  5. Michael at 7:52 am

    I was told at The Cleveland Clinic to “…Only try this right before suicide” – Dr. Tepper. – because the chances of having a stroke and becoming paralyzed was VERY HIGH. They did NOT see this as a form of successful treatment for anything.
    Articles like this are posted because the surgeons and companies that make these devices want MORE $$$$$$$ !!!

  6. Christina Claycomb at 10:19 pm

    I’ve been living in pain for SO long. I would be the first 1 standing in line to try a DBS…I will NVR loose hope! I remember it being mentioned way back in 2005 by Dr. Rezai

  7. cindy d at 3:42 pm

    I have to agree with Kathy C. While I do appreciate that NPR is keeping us informed on what’s happening. Some of these “studies” are just spin.

  8. Kathy C at 9:11 am

    Meh!
    I used to think at some point people would become aware of the Sham these silly Articles really are. The real question is, why are they even put on this page. The only thing this “Study” shows is the lengths these so called researchers will go to get Published. They did nto achieve their “Endpoint” which was pain reduction or control, so they salvaged it with Woo. “Depression, Anxiety and Quality of Life,” all subjective. Their Bias and manipulation of the Scientific Method, are outrageous. The small number of test subjects is a giveaway too.
    This “Study” was designed to mislead and appeal to the Sciency as Deep Brain Stimulation was touted as a “Breakthrough.” All of the Popular “Science Magazines,and the New Age, Psychobabble Industry has glommed on to this fascinating new technology. The only thing this “Study” shows is how inconclusive results can be spun to hype a new technology, and at the same time mislead a gullible public. The Psych Industry will do doubt reprint or refer to this nonsense to give the appearance of credibility to another stupid and unscientific “Theory” of theirs. Deep Brain Stimulation might have some kind of application in the future, but this New Agey pseudo Scientific nonsense here makes is look like a dead end.

  9. Ibin at 7:25 am

    ANY method of pain relief to those of us “living” with and “in” continuous pain, would be a great relief. Pain, eternal, continuous pain, takes incredible will power to contend with. Pain is a signal that “something” is amiss in the body. Pain caused by disease, injury, and or the attempt to “cure” the underlying cause of pain. Millions of people can not find sufficient relief.

    The pain patient does not wish for their perception, normal perception of the world in view, to be altered. The patient just wishes to be released of the pain. In my naivety, I have actually asked IF the pain generating cause, the nerves if you will, could simply be severed. The underlying cause of pain is not so simple to identify and is not easily “shut down”..

    The “promise” of neuromodulation, deep brain stimulation, if it could really work for some types of pain relief “sounds”….great. How long before it becomes reality for the masses? Is this method of relief for the masses of people living in pain? I have used a “tens” unit. The unit does NOT relieve pain, it only distracts the pain…..for a small period of time. The patient learns to be able to set the unit at its highest level to distract the pain being felt.
    My Father had “neuropathy” in his feet. The bottom of his feet. He had a “tens” unit surgically implanted. He nor his siblings, or parents, did not wish to use opiate pain relievers.Perhaps if he had used medication, he would still be here, today. Sadly, after a year and one half of electrical pain “relief”, he could no longer tolerate the pain He took his own life.

    I am all in, for an alternate method of continuous pain relief that really works. Taking oral medication day in, day out, is expensive, time consuming, and may have variations of “allergic” reactions to some patients but, for the time being, and for 1000’s of years past, it is the ONLY way for many patients to relieve constant, severe pain. Would the concept of research and developing alternate ways to manage pain WHILE being sufficiently treated for pain with medication make any common sense?

    I believe that some, maybe all “chronic” pain, can be managed……some time in the future. For now, people with continuous pain that NEED to tend their children, be a part of their academic life, go to the “grocery” store, prepare their meals, transport themselves to the physician, and mange to take care of their personal hygiene has not stopped. Yet, sufficient medication, used by millions, safely, effectively, through examinations, evaluations, and prescribing in an adequate dose has stopped. Life goes on, with the “promise” of alternative treatment for the pain patient, soon to come.

    I do not advocate for any one particular medication, and especially not for the “premise” that a maximum dose is sufficient “for one and all”. It is an asinine concept in the attempt to change social consciousness. If one pain patient can adjust to a much lowered dose of opiate medication then, everyone can, as per “DOT/GOV”. What ludicrous “thinking” by DOT.GOV.

    Life goes on. How many pain patients that were able to be self reliant previous to the mis-guided-line can no longer work to pay there recurring debt? Even if your home is paid for or your rent is “paid up” for 5 years, utility charges are still due. Food gathering and preparation doesn’t stop.Fuel to provide transportation or heat and cooling still remains a cost of living. Our sovereignty, our self reliance, independence, even if totally disabled has been altered, negatively, without substantiation, changed if not completely stopped while alternate methods of pain management are being researched, tested, theorized, and “promised”.

    Pain patients, the patient who ONLY wishes pain to be reduced to a humanly tolerable level have been affected in a very serious way. CDC states the reason for 90mme, daily is to lower the rate of mortality in association with “opioids”. If ALL opiate medication was prohibited, which some of our elected people advocate, how much lower would the mortality rate without prescription opiate based medication REALLY be reduced? Where there is a market for the recreational opiate user is concerned, the, a product WILL find its way into their possession.

    Opiate based drugs, illicit drugs, will continue to be a part of this nations problems. 90 mme daily will only negatively affect the unfortunate people with continuous pain. I think ALL pain patients are in favor of alternate, effective pain relief but, why torture pain patients that have used medication, beneficially for years, decades without subsequent health harm for those who use responsibility with their medication?

    It has been stated that a physicians’ life is made “easier” IF the patient thinks that the doctor is limited as to the amount and type medication prescribed. What about the patients that have been stably treated on a dosage and type medication without the request for”more”. The patient realizes that ALL pain from a disease or injury can not be alleviated. Pain relief is a compromise between true suffering and the ability at least function, in some capacity.

    How many “promises” for alternate pain relief fail? How long will R& D take before the NOW pain patient can get just sufficient relief for a condition not asked for. A painful condition that may be hereditary. Pain caused by accidental injury. Alcohol prohibition did not succeed..How can causing unwarranted suffering by prohibition curb irresponsible use of “drugs”. We have in this world different races of people, different mentalities of people, men, women, adults, children, different philosophies of “life” and different religions. 90 mme daily, the one shoe fits all pain patient “regulation” of pain relief at least in my lifetime is the most arrogant, asinine “policy” ever placed on the human being destined to fail I, have ever witnessed.

    “GOOD” people do exist. Responsible people. People that volunteer to run into a burning building while the occupants are running out. People that listen to “scanners”. radios, for an emergency health issue that are willing to assist the patient until a medical transport unit arrives. These people volunteer to train, at their own expense and time, just to help their fellow “man” in time of emergency. DOT/GOV in their mis-guided attempt to control social consciousness, change the thought pattern of the unfortunate folks that have fallen upon such distress in life that they turn, or some even choose to escape responsibility with illicit substances. These people, our people, need different measures to help those folks to perceive life, worth living. Maybe not even for their personal sake but, for their childrens’ “welfare”, an aging parent, or just out of the instilled knowledge that humanity., still exists. Promising, alternative, pain relief methodology does not, at this time relieve constant pain. If it did, I would promise myself that I could sleep, promise myself that I would no longer suffer unmanageable pain. Promise others, a manageable pain level will happen, now.

  10. HJ at 6:43 am

    Uh, NO.

    So, leave the person in pain and make them feel better about being in pain?!?!

    Affective = EMOTIONS
    Analgesia = Pain relief

    And they’re doing brain surgery on these folks? What is the “sham” deep brain stimulation? I’m hoping that means they at least got the implants but the system wasn’t turned on until later.

    Could these post-stroke patients understand what they’d signed up for? Did they give informed consent? I imagine this is explained in the full study but I feel queasy.

    How ethical is it to do brain surgery to make someone feel better about having pain when they still have to LIVE with the pain?

    I am sure that pain and emotions are inter-related, but as someone with pain, I understand more than these researchers, apparently. This is how I explain my situation to my doctors: “When pain limits my abilities to do the things that I enjoy doing, I become depressed.”

    Pain is an obstacle to doing some of the things that I love to do… or USED to love to do. I used to think nothing of getting up early and spending a day running all over town (on public transit, no less). I used to plan to visit different neighborhoods to go exploring. Not anymore… A few hours away from home is very tiring because of the pain in my feet, hips, lower back and neck in particular and I become eager to get home and rest to regain some energy (if I even benefit much from the rest – because it takes longer for me to recover than it used to).

    Yet, I miss being able to spend a whole day away from home and instead have tried to find activities that I can enjoy at home or closer to home. My plans away from home are much more moderate, but I often find myself planning beyond my capacity and reality scales things back if my own common sense doesn’t kick in. It’s a big disappointment when I can’t carry out my plans for the day.

    I reach a limit that the pain wears me down physically. I often become stiff and achy from the osteoarthritis, degenerative disc disease and cervical spondylosis. And then, I regretfully decide that it’s time to go home and rest.

    Pain has real, legitimate effects and limitations. These researchers are barking up the wrong tree to suggest that Affective treatment should take precedence over Analgesic treatment.

    This is the kind of research that makes me want to knock sense into people. OMG. Be assured, I’ve faced many doctors who have barked up a similar tree and I’ve just decided to move on to doctors who have common sense.

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