seizures in the terminal three months of stimulation at three years measuring a median 58%
reduction compared to baseline. In the blinded phase, stimulation produced significant
reduction in injuries due to seizures, frequency of complex partial seizures, seizures
originating from the temporal lobes and seizures pre-designated as “most severe” by the
patient. Responder rates for 50% improvement and quality of life did not significantly
improve during the three-month blinded phase, but did in the open-label and long-term
follow-up stages from 1 to 3 years after implantation. In the long-term phase, 14% of
patients became seizure-free for at least 6 months. Patients who previously had not
benefitted from vagus nerve stimulation or epilepsy surgery had the same favorable response
to DBS as did the overall group.
Complications of stimulation consisted of occasional chest or other paresthesias, need for
repositioning leads, and superficial infections. No symptomatic brain hemorrhages were
seen, though neuroimaging showed asymptomatic blood in five patients.
Neuropsychological tests showed no difference in cognitive or profiles of mood scores, but
more stimulated patients reported symptoms of depression and memory impairment. Five
patients had status epilepticus, two related to initiation of stimulation, and resolving with
reduction of voltage. Rates of depression, status epilepticus, depression, suicide and sudden
unexpected death in epilepsy (SUDEP) all were within the expected ranges for a population
of people with refractory epilepsy.
The conclusion of the SANTE study was that stimulation of the anterior nuclei of thalamus
reduced the number of seizures in patients with medication-resistant epilepsy. Complications
were similar to those encountered with DBS for movement disorders, with additional
concerns raised about possible subjective symptoms of depression and memory impairment
seizures in the terminal three months of stimulation at three years measuring a median 58%reduction compared to baseline. In the blinded phase, stimulation produced significantreduction in injuries due to seizures, frequency of complex partial seizures, seizuresoriginating from the temporal lobes and seizures pre-designated as “most severe” by thepatient. Responder rates for 50% improvement and quality of life did not significantlyimprove during the three-month blinded phase, but did in the open-label and long-termfollow-up stages from 1 to 3 years after implantation. In the long-term phase, 14% ofpatients became seizure-free for at least 6 months. Patients who previously had notbenefitted from vagus nerve stimulation or epilepsy surgery had the same favorable responseto DBS as did the overall group.Complications of stimulation consisted of occasional chest or other paresthesias, need forrepositioning leads, and superficial infections. No symptomatic brain hemorrhages wereseen, though neuroimaging showed asymptomatic blood in five patients.Neuropsychological tests showed no difference in cognitive or profiles of mood scores, butmore stimulated patients reported symptoms of depression and memory impairment. Fivepatients had status epilepticus, two related to initiation of stimulation, and resolving withreduction of voltage. Rates of depression, status epilepticus, depression, suicide and suddenunexpected death in epilepsy (SUDEP) all were within the expected ranges for a populationof people with refractory epilepsy.The conclusion of the SANTE study was that stimulation of the anterior nuclei of thalamusreduced the number of seizures in patients with medication-resistant epilepsy. Complicationswere similar to those encountered with DBS for movement disorders, with additionalconcerns raised about possible subjective symptoms of depression and memory impairment
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