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Ethical issues raised around deep brain stimulation (DBS) research

Researchers grap­ple with the ethics of test­ing brain implants (Sci­ence):

In 2003, neu­rol­o­gist Helen May­berg of Emory Uni­ver­si­ty in Atlanta began to test a bold, exper­i­men­tal treat­ment for peo­ple with severe depres­sion, which involved implant­i­ng met­al elec­trodes deep in the brain in a region called area 25. The ini­tial data were promis­ing; even­tu­al­ly, they con­vinced a device com­pa­ny, St. Jude Med­ical in Saint Paul, to spon­sor a 200-per­son clin­i­cal tri­al dubbed BROADEN.

This month, how­ev­er, Lancet Psy­chi­a­try report­ed the first pub­lished data on the trial’s fail­ure. The study stopped recruit­ing par­tic­i­pants in 2012, after a 6‑month study in 90 peo­ple failed to show sta­tis­ti­cal­ly sig­nif­i­cant improve­ments between those receiv­ing active stim­u­la­tion and a con­trol group, in which the device was implant­ed but switched off.

Although that deci­sion was “game over” for BROADEN, the sto­ry wasn’t fin­ished for some 44 patients who asked to keep the implants in their brains, and the clin­i­cians respon­si­ble for their long-term care,  May­berg explained last week to col­leagues at a meet­ing on the eth­i­cal dilem­mas of brain stim­u­la­tion research at the Nation­al Insti­tutes of Health (NIH) in Bethes­da, Maryland…A forth­com­ing report from the meet­ing will also exam­ine oth­er eth­i­cal issues researchers might need to con­sid­er, includ­ing the large­ly unknown, long-term effects of stim­u­la­tion on the brain, and how to obtain prop­er con­sent from par­tic­i­pants.”

The Study

Sub­cal­los­al cin­gu­late deep brain stim­u­la­tion for treat­ment-resis­tant depres­sion: a mul­ti­site, ran­domised, sham-con­trolled tri­al (Lancet Psy­chi­a­try). From the abstract:

  • Back­ground: Deep brain stim­u­la­tion (DBS) of the sub­cal­los­al cin­gu­late white mat­ter has shown promise as an inter­ven­tion for patients with chron­ic, unremit­ting depres­sion. To test the safe­ty and effi­ca­cy of DBS for treat­ment-resis­tant depres­sion, a prospec­tive, ran­domised, sham-con­trolled tri­al was con­duct­ed.
  • Find­ings: …90 par­tic­i­pants were ran­dom­ly assigned to active (n=60) or sham (n=30) stim­u­la­tion between April 10, 2008, and Nov 21, 2012. Both groups showed improve­ment, but there was no sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in response dur­ing the dou­ble-blind, sham-con­trolled phase (12 [20%] patients in the stim­u­la­tion group vs five [17%] patients in the con­trol group). 28 patients expe­ri­enced 40 seri­ous adverse events; eight of these (in sev­en patients) were deemed to be relat­ed to the study device or surgery.
  • Inter­pre­ta­tion: This study con­firmed the safe­ty and fea­si­bil­i­ty of sub­cal­los­al cin­gu­late DBS as a treat­ment for treat­ment-resis­tant depres­sion but did not show sta­tis­ti­cal­ly sig­nif­i­cant anti­de­pres­sant effi­ca­cy in a 6‑month dou­ble-blind, sham-con­trolled tri­al. Future stud­ies are need­ed to inves­ti­gate fac­tors such as clin­i­cal fea­tures or elec­trode place­ment that might improve effi­ca­cy.

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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