Focal Cortex Stimulation With a Novel Implantable Device and Antiseizure Outcomes in 2 Prospective Multicenter Single-Arm Trials
Importance: For the large population of people with drug-refractory epilepsy, alternative treatment approaches are needed. Clinical trial outcomes of a novel stimulation device, which is newly available in Europe for the treatment of patients with a predominant seizure focus, are reported for the first time.
Objective: To perform a pooled analysis of the results of 2 prospective, multicenter, single-arm trials, A Pilot Study to Assess the Feasibility of Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (EASEE II) and A Pilot Study to Assess the Feasibility of Patient-Controlled Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (PIMIDES I), assessing the safety and efficacy of epicranial focal cortex stimulation (FCS) with a novel implantable device (EASEE [Precisis]) as adjunctive treatment for adult patients with drug-refractory focal epilepsy.
Design, Setting, and Participants: This study was a pooled analysis of 2 nonrandomized uncontrolled trials, EASEE II and PIMIDES I, which began on January 15, 2019, and January 14, 2020, respectively, and ended on July 28, 2021. EASEE II and PIMIDES I were the first in-human, prospective, single-arm trials with an 8-month evaluation period. Patients were recruited at 7 European epilepsy centers. Consecutive participants with drug-refractory focal epilepsy were enrolled. Study data were analyzed from September 29, 2021, to February 2, 2022.
Interventions: After a 1-month prospective baseline period, patients were implanted with the neurostimulation device. After a 1-month postimplantation recovery period, unblinded FCS was activated using both high-frequency and direct current (DC)-like components performed via electrode arrays placed epicranially above the individual epileptic focus region.
Main Outcomes and Measures: Efficacy was prospectively assessed by the responder rate in the sixth month of stimulation compared with baseline; safety and additional end points were assessed after device implantation and during the stimulation period.
Results: Of the 34 adult patients enrolled at 6 German and 1 Belgian investigational site, 33 (mean [SD] age, 34.6 [13.5] years; 18 male patients [54.5%]) received the neurostimulation device implant. A total of 32 patients underwent combined high-frequency direct current-like stimulation at least until the 8-month postimplant follow-up visit. After 6 months of stimulation, 17 of 32 patients (53.1%) were responders to treatment with at least a 50% reduction in seizure frequency compared with baseline, corresponding to a significant median seizure reduction by 52% (95% CI, 0.37%-0.76%; P < .001). No device- or procedure-related serious adverse events were reported (0; 95% CI, 0%-10.58%). There were no significant alterations in cognition, mood, or overall quality of life.
Conclusions and Relevance: Results of this pooled analysis of 2 nonrandomized uncontrolled trials suggest that FCS with a novel neurostimulation device was associated with an effective reduction in seizure frequency in patients with drug-refractory focal epilepsy and may offer a promising treatment option for patients with a predominant epileptic focus.
Trial Registration: German Clinical Trials Register: DRKS00015918 and DRKS00017833, respectively, and jointly under PROSPERO: CRD42021266440.
| Errataetall: |
ErratumIn: JAMA Neurol. 2023 Nov 1;80(11):1253. - PMID 37782493 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:80 |
|---|---|
| Enthalten in: |
JAMA neurology - 80(2023), 6 vom: 01. Juni, Seite 588-596 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Schulze-Bonhage, Andreas [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Anticonvulsants |
|---|
| Anmerkungen: |
Date Completed 14.06.2023 Date Revised 02.10.2023 published: Print ErratumIn: JAMA Neurol. 2023 Nov 1;80(11):1253. - PMID 37782493 Citation Status MEDLINE |
|---|
| doi: |
10.1001/jamaneurol.2023.0066 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM355156407 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM355156407 | ||
| 003 | DE-627 | ||
| 005 | 20231226063742.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1001/jamaneurol.2023.0066 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1183.xml |
| 035 | |a (DE-627)NLM355156407 | ||
| 035 | |a (NLM)37010826 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Schulze-Bonhage, Andreas |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Focal Cortex Stimulation With a Novel Implantable Device and Antiseizure Outcomes in 2 Prospective Multicenter Single-Arm Trials |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 14.06.2023 | ||
| 500 | |a Date Revised 02.10.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a ErratumIn: JAMA Neurol. 2023 Nov 1;80(11):1253. - PMID 37782493 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: For the large population of people with drug-refractory epilepsy, alternative treatment approaches are needed. Clinical trial outcomes of a novel stimulation device, which is newly available in Europe for the treatment of patients with a predominant seizure focus, are reported for the first time | ||
| 520 | |a Objective: To perform a pooled analysis of the results of 2 prospective, multicenter, single-arm trials, A Pilot Study to Assess the Feasibility of Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (EASEE II) and A Pilot Study to Assess the Feasibility of Patient-Controlled Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (PIMIDES I), assessing the safety and efficacy of epicranial focal cortex stimulation (FCS) with a novel implantable device (EASEE [Precisis]) as adjunctive treatment for adult patients with drug-refractory focal epilepsy | ||
| 520 | |a Design, Setting, and Participants: This study was a pooled analysis of 2 nonrandomized uncontrolled trials, EASEE II and PIMIDES I, which began on January 15, 2019, and January 14, 2020, respectively, and ended on July 28, 2021. EASEE II and PIMIDES I were the first in-human, prospective, single-arm trials with an 8-month evaluation period. Patients were recruited at 7 European epilepsy centers. Consecutive participants with drug-refractory focal epilepsy were enrolled. Study data were analyzed from September 29, 2021, to February 2, 2022 | ||
| 520 | |a Interventions: After a 1-month prospective baseline period, patients were implanted with the neurostimulation device. After a 1-month postimplantation recovery period, unblinded FCS was activated using both high-frequency and direct current (DC)-like components performed via electrode arrays placed epicranially above the individual epileptic focus region | ||
| 520 | |a Main Outcomes and Measures: Efficacy was prospectively assessed by the responder rate in the sixth month of stimulation compared with baseline; safety and additional end points were assessed after device implantation and during the stimulation period | ||
| 520 | |a Results: Of the 34 adult patients enrolled at 6 German and 1 Belgian investigational site, 33 (mean [SD] age, 34.6 [13.5] years; 18 male patients [54.5%]) received the neurostimulation device implant. A total of 32 patients underwent combined high-frequency direct current-like stimulation at least until the 8-month postimplant follow-up visit. After 6 months of stimulation, 17 of 32 patients (53.1%) were responders to treatment with at least a 50% reduction in seizure frequency compared with baseline, corresponding to a significant median seizure reduction by 52% (95% CI, 0.37%-0.76%; P < .001). No device- or procedure-related serious adverse events were reported (0; 95% CI, 0%-10.58%). There were no significant alterations in cognition, mood, or overall quality of life | ||
| 520 | |a Conclusions and Relevance: Results of this pooled analysis of 2 nonrandomized uncontrolled trials suggest that FCS with a novel neurostimulation device was associated with an effective reduction in seizure frequency in patients with drug-refractory focal epilepsy and may offer a promising treatment option for patients with a predominant epileptic focus | ||
| 520 | |a Trial Registration: German Clinical Trials Register: DRKS00015918 and DRKS00017833, respectively, and jointly under PROSPERO: CRD42021266440 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Anticonvulsants |2 NLM | |
| 700 | 1 | |a Hirsch, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Knake, Susanne |e verfasserin |4 aut | |
| 700 | 1 | |a Kaufmann, Elisabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Kegele, Josua |e verfasserin |4 aut | |
| 700 | 1 | |a Rademacher, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Vonck, Kristl |e verfasserin |4 aut | |
| 700 | 1 | |a Coenen, Volker Arnd |e verfasserin |4 aut | |
| 700 | 1 | |a Glaser, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Jenkner, Carolin |e verfasserin |4 aut | |
| 700 | 1 | |a Winter, Yaroslav |e verfasserin |4 aut | |
| 700 | 1 | |a Groppa, Sergiu |e verfasserin |4 aut | |
| 700 | 0 | |a EASEE Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Borger, Valerie |e investigator |4 oth | |
| 700 | 1 | |a Dewaele, Frank |e investigator |4 oth | |
| 700 | 1 | |a Kunz, Mathias |e investigator |4 oth | |
| 700 | 1 | |a Naros, Georgios |e investigator |4 oth | |
| 700 | 1 | |a Nimsky, Christopher |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t JAMA neurology |d 2013 |g 80(2023), 6 vom: 01. Juni, Seite 588-596 |w (DE-627)NLM221640614 |x 2168-6157 |7 nnns |
| 773 | 1 | 8 | |g volume:80 |g year:2023 |g number:6 |g day:01 |g month:06 |g pages:588-596 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1001/jamaneurol.2023.0066 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 80 |j 2023 |e 6 |b 01 |c 06 |h 588-596 | ||