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COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy

Robert Fisher, Vicenta Salanova, Thomas Witt, Robert Worth, Thomas Henry, Robert Gross, Kalarickal Oommen, Ivan Osorio, Jules Nazzaro, Douglas Labar, Michael Kaplitt, Michael Sperling, Evan Sandok, John Neal, Adrian Handforth, John Stern, Antonio DeSalles, Steve Chung, Andrew Shetter, Donna Bergen, Roy Bakay, Jaimie Henderson, Jacqueline French, Gordon Baltuch, William Rosenfeld, Andrew Youkilis, William Marks, Paul Garcia, Nicolas Barbaro, Nathan Fountain, Carl Bazil, Robert Goodman, Guy McKhann, K Babu Krishnamurthy, Steven Papavassiliou, Charles Epstein, John Pollard, Lisa Tonder, Joan Grebin, Robert Coffey, Nina Graves
Epilepsia 2010, 51 (5): 899-908
20331461

PURPOSE: We report a multicenter, double-blind, randomized trial of bilateral stimulation of the anterior nuclei of the thalamus for localization-related epilepsy.

METHODS: Participants were adults with medically refractory partial seizures, including secondarily generalized seizures. Half received stimulation and half no stimulation during a 3-month blinded phase; then all received unblinded stimulation.

RESULTS: One hundred ten participants were randomized. Baseline monthly median seizure frequency was 19.5. In the last month of the blinded phase the stimulated group had a 29% greater reduction in seizures compared with the control group, as estimated by a generalized estimating equations (GEE) model (p = 0.002). Unadjusted median declines at the end of the blinded phase were 14.5% in the control group and 40.4% in the stimulated group. Complex partial and "most severe" seizures were significantly reduced by stimulation. By 2 years, there was a 56% median percent reduction in seizure frequency; 54% of patients had a seizure reduction of at least 50%, and 14 patients were seizure-free for at least 6 months. Five deaths occurred and none were from implantation or stimulation. No participant had symptomatic hemorrhage or brain infection. Two participants had acute, transient stimulation-associated seizures. Cognition and mood showed no group differences, but participants in the stimulated group were more likely to report depression or memory problems as adverse events.

DISCUSSION: Bilateral stimulation of the anterior nuclei of the thalamus reduces seizures. Benefit persisted for 2 years of study. Complication rates were modest. Deep brain stimulation of the anterior thalamus is useful for some people with medically refractory partial and secondarily generalized seizures.

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