FDA OKs Brain Stimulator for Depression
The US Food and Drug Administration has approved an electrical brain stimulator which delivers tiny shocks as a treatment for severe depression. A generator the size of a pocket watch is implanted into the chest, and wires snake up the neck to the vagus nerve, delivering tiny electric shocks through that nerve and into a region of the brain thought to play a role in mood.
The American Psychological Association reports on a decision by the US government to approve a new therapy for the severely depressed who have run out of treatment options: a pacemaker-like implant that sends tiny electric shocks to the brain. The vagus nerve stimulator, made by a company called Cyberonics, will now be available to the estimated 4 million Americans with hard-to-treat depression — despite controversy over whether it’s really been proven to work.
“These are patients pretty much at the end of the line in terms of what treatment options are available to them,” said FDA medical device chief Dr. Daniel Schultz, who said he personally was persuaded by Cyberonics’ research despite initial skepticism within his agency.
Cyberonics began a 200-patient study to see whether VNS could treat depression patients not adequately helped by other therapies. An FDA review last year found no difference after three months of implant treatment. Cyberonics argued that a year later, a significant number of the VNS recipients had had their depression ease.
However, that yearlong follow-up hadn’t been done according to standard scientific procedures — it wasn’t a randomized controlled study — and thus critics questioned its validity.
Cyberonics continued to track the VNS recipients, and two years later a third of patients in the original study had experienced some response and between 17 percent and 20 percent were in remission, Schultz said, evidence he ultimately found persuasive.
Still, critics have complained that without a comparison group, it’s unclear if the implant really helped or the depression eased for some other reason.
Schultz said there are some safety warnings. The chief risk: More than half of patients in the depression study experienced at least temporary voice alterations - a hoarseness or raspiness, or voice “breaks” - that seem to persist in a significant number, he said.
Other complications include difficulty breathing or swallowing, he said. Deaths have been reported among some epilepsy patients who have a VNS implant, but Schultz said there was no sign of increased deaths in the depression study.
See our earlier article “Transcranial Magnetic Stimulation for Depression” for details about transcranial magnetic stimulation, another new treatment for severe depression that appears to be significantly better supported by scientific evidence.
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This article was last reviewed by on Monday, 18th July 2005. You can leave a response below.
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19th July 2005
Hmmm…the next time I’m severely depressed I don’t think I’ll look into this as an option, whether they can find a med combo to get me back to functioning or not.
20th July 2005
The thought of having electrical shocks delivered into the brain on a regular basis doesn’t seem very appealing? I have to admit it seems pretty radical to me — and a bit worrying, given that the actual evidence for it seems sketchy at best.
On the other hand, if I were severely depressed, and felt like nothing else had helped, I might be grateful for one more option.
All the best,
Greg
7th September 2005
I am desperatly trying to get this procedure done ASAP. After exausting everything else(Meds since 1977 and ECT). Do you blame me? Those who are skeptical must not know the depths of this grusome disease!
8th September 2005
Hi Mary,
You’ve tried several other options, including ECT, and by the sounds of it, these haven’t helped to relieve the symptoms you’re experiencing. In that context, I can really understand your wanting to try this as another possibility. If you feel like it, please do let us know how it works out.
All the best,
Greg
25th September 2006
Mary:
Has anyone had any luck getting a VNS implant in the U.S. - AND gotten Medicare to pay for the procedure?
My girlfriend suffers from treatment-resistant depression and bipolar disorder. She has been through everything, including two rounds of ECT (I think she had 7-10 ‘treatments’ each time) in 2003/4. She is at her wits end - any advice from someone who has successfully sought this from Medicare would be gratefully appreciated!
- a dear friend of one of the tortured ones
29th October 2006
I have treatment-resistant depression and rapid cycling bipolar.I am desperate…I have not tried ECT, does it ever help? I am even considering this VNS, but am very wary…I have been struggling since the 1980’s….and it has only gotten worse, no matter what I try, not even the hospitalizations. How much more desperate can a person get? Sometimes I think I would even consider that lobotomy idea.