SUMMARY
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 signifi-
cantly 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.
KEY WORDS: Epilepsy, Seizures, Deep brain stimulation,
Epilepsy surgery, Thalamus.
SUMMARYPurpose: We report a multicenter, double-blind, randomizedtrial of bilateral stimulation of the anterior nuclei ofthe thalamus for localization-related epilepsy.Methods: Participants were adults with medically refractorypartial seizures, including secondarily generalizedseizures. Half received stimulation and half no stimulationduring a 3-month blinded phase; then all receivedunblinded stimulation.Results: One hundred ten participants were randomized.Baseline monthly median seizure frequency was 19.5. Inthe last month of the blinded phase the stimulated grouphad a 29% greater reduction in seizures compared withthe control group, as estimated by a generalized estimatingequations (GEE) model (p = 0.002). Unadjusted mediandeclines at the end of the blinded phase were 14.5% inthe control group and 40.4% in the stimulated group.Complex partial and ‘‘most severe’’ seizures were signifi-cantly reduced by stimulation. By 2 years, there was a 56%median percent reduction in seizure frequency; 54% ofpatients had a seizure reduction of at least 50%, and 14patients were seizure-free for at least 6 months. Fivedeaths occurred and none were from implantation orstimulation. No participant had symptomatic hemorrhageor brain infection. Two participants had acute, transientstimulation-associated seizures. Cognition andmood showed no group differences, but participants inthe stimulated group were more likely to report depressionor memory problems as adverse events.Discussion: Bilateral stimulation of the anterior nuclei ofthe thalamus reduces seizures. Benefit persisted for2 years of study. Complication rates were modest. Deepbrain stimulation of the anterior thalamus is useful forsome people with medically refractory partial and secondarilygeneralized seizures.KEY WORDS: Epilepsy, Seizures, Deep brain stimulation,Epilepsy surgery, Thalamus.
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