Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Hälbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltête D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Krüger R, Pinsker MO, Amtage F, Régis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G, .
Neurostimulation for Parkinson's disease with early motor complications.
N Engl J Med. 2013 Feb 14;368(7):610-22.
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I think the trial is too short (two years) to address the most important caveat: the loss of DBS efficacy over time. Hence, the trial is not well conceived, in my opinion.
Another issue is that the actual rationale for DBS use—as the authors themselves state in the introduction—is to deal with serious dyskinetic side effects that develop with extended use of pharmacological therapies.
Given that DBS is not a restorative treatment—such as replacing or restoring the original neurons—this effort may drive up the use of this technology to new patient groups who are less likely to benefit from this treatment over a decade than they might from pharmacological or other therapies. And DBS brings significant risks for complications. The use of DBS, and the risks associated with the implantation and the non-physiological electrical stimulation on diverse neural brain circuitries are not known.