Abstract
Purpose: The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint. Methods: The study was a multicenter randomized controlled double-blinded trial of responsive neurostimulation in 191 patients with medically resistant focal epilepsy. During a 4-month postimplant blinded period, patients were randomized to receive responsive stimulation or sham stimulation, after which all patients received responsive neurostimulation in open label to complete 2. years. Quality of life (QOL) and mood surveys were administered during the baseline period, at the end of the blinded period, and at year 1 and year 2 of the open label period. Results: The treatment and sham groups did not differ at baseline. Compared with baseline, QOL improved in both groups at the end of the blinded period and also at 1. year and 2. years, when all patients were treated. At 2. years, 44% of patients reported meaningful improvements in QOL, and 16% reported declines. There were no overall adverse changes in mood or in suicidality across the study. Findings were not related to changes in seizures and antiepileptic drugs, and patients with mesial temporal seizure onsets and those with neocortical seizure onsets both experienced improvements in QOL. Conclusions: Treatment with targeted responsive neurostimulation does not adversely affect QOL or mood and may be associated with improvements in QOL in patients, including those with seizures of either mesial temporal origin or neocortical origin.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 242-247 |
| Number of pages | 6 |
| Journal | Epilepsy and Behavior |
| Volume | 45 |
| DOIs | |
| State | Published - Apr 1 2015 |
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Keywords
- Brain stimulation
- Depression
- Epilepsy
- Intractable seizures
- Quality of life
- Responsive stimulation
ASJC Scopus subject areas
- Clinical Neurology
- Behavioral Neuroscience
- Neurology
Cite this
Quality of life and mood in patients with medically intractable epilepsy treated with targeted responsive neurostimulation. / RNS System Pivotal Trial Investigators.
In: Epilepsy and Behavior, Vol. 45, 01.04.2015, p. 242-247.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Quality of life and mood in patients with medically intractable epilepsy treated with targeted responsive neurostimulation
AU - RNS System Pivotal Trial Investigators
AU - Meador, Kimford J.
AU - Kapur, Ritu
AU - Loring, David W.
AU - Kanner, Andres M
AU - Morrell, Martha J.
PY - 2015/4/1
Y1 - 2015/4/1
N2 - Purpose: The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint. Methods: The study was a multicenter randomized controlled double-blinded trial of responsive neurostimulation in 191 patients with medically resistant focal epilepsy. During a 4-month postimplant blinded period, patients were randomized to receive responsive stimulation or sham stimulation, after which all patients received responsive neurostimulation in open label to complete 2. years. Quality of life (QOL) and mood surveys were administered during the baseline period, at the end of the blinded period, and at year 1 and year 2 of the open label period. Results: The treatment and sham groups did not differ at baseline. Compared with baseline, QOL improved in both groups at the end of the blinded period and also at 1. year and 2. years, when all patients were treated. At 2. years, 44% of patients reported meaningful improvements in QOL, and 16% reported declines. There were no overall adverse changes in mood or in suicidality across the study. Findings were not related to changes in seizures and antiepileptic drugs, and patients with mesial temporal seizure onsets and those with neocortical seizure onsets both experienced improvements in QOL. Conclusions: Treatment with targeted responsive neurostimulation does not adversely affect QOL or mood and may be associated with improvements in QOL in patients, including those with seizures of either mesial temporal origin or neocortical origin.
AB - Purpose: The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint. Methods: The study was a multicenter randomized controlled double-blinded trial of responsive neurostimulation in 191 patients with medically resistant focal epilepsy. During a 4-month postimplant blinded period, patients were randomized to receive responsive stimulation or sham stimulation, after which all patients received responsive neurostimulation in open label to complete 2. years. Quality of life (QOL) and mood surveys were administered during the baseline period, at the end of the blinded period, and at year 1 and year 2 of the open label period. Results: The treatment and sham groups did not differ at baseline. Compared with baseline, QOL improved in both groups at the end of the blinded period and also at 1. year and 2. years, when all patients were treated. At 2. years, 44% of patients reported meaningful improvements in QOL, and 16% reported declines. There were no overall adverse changes in mood or in suicidality across the study. Findings were not related to changes in seizures and antiepileptic drugs, and patients with mesial temporal seizure onsets and those with neocortical seizure onsets both experienced improvements in QOL. Conclusions: Treatment with targeted responsive neurostimulation does not adversely affect QOL or mood and may be associated with improvements in QOL in patients, including those with seizures of either mesial temporal origin or neocortical origin.
KW - Brain stimulation
KW - Depression
KW - Epilepsy
KW - Intractable seizures
KW - Quality of life
KW - Responsive stimulation
UR - http://www.scopus.com/inward/record.url?scp=84937760662&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84937760662&partnerID=8YFLogxK
U2 - 10.1016/j.yebeh.2015.01.012
DO - 10.1016/j.yebeh.2015.01.012
M3 - Article
C2 - 25819949
AN - SCOPUS:84937760662
VL - 45
SP - 242
EP - 247
JO - Epilepsy and Behavior
JF - Epilepsy and Behavior
SN - 1525-5050
ER -