[Implantable neurostimulation device for the treatment of drug-resistant pediatric epilepsy]
Ramos-García V, Álvarez-Pérez Y, Abt-Sacks A, Rivero-Santana A, Duarte-Díaz A, Perestelo-Pérez L, Santos-Álvarez A, González-Hernández Y, Rodríguez-Rodríguez L, Rivas-Luis F, Serrano-Aguilar P
Record ID 32018005323
Spanish
Original Title:
Dispositivo de neuroestimulación implantable para el tratamiento de la epilepsia pediátrica farmacorresistente
Authors' results and conclusions:
Key Points
• Epilepsy is a neurological condition that affects approximately
10.5 million of the world population under 15 years of age. In
Spain, its incidence is estimated at 3.7 cases per 1000 inhabitants
between 6 and 14 years of age. Epilepsy is the third most common
cause of neurological care in emergency services in the Spanish
context. It is estimated that between 8-33% of epilepsies are drug
resistant.
• Having epilepsy is associated with an increased risk of physical
problems, such as fractures or bruising, from seizure-related
trauma. Cognitive (intellectual disability) and behavioral
(neurobehavioral problems) comorbidities are more common
among drug-resistant children and those with a high seizure
burden.
• The use of responsive neurostimulation (RNS) systems in
combination with the usual treatment -drugs- could improve the
control of epileptic seizures in pediatric patients who are not
candidates for brain surgery, contributing to a better quality of life
for the patients and their families.
• The review of the evidence did not identify any clinical trials
comparing the use of the RNS against usual drug treatment in the
pediatric population. Case series studies found to date show that
a large proportion of pediatric patients respond to RNS, with a 50-
75% reduction in seizure frequency. Seizure intensity and
duration are also reported to be lower after using RNS. The
adverse effects of the RNS implantation process were related to
infections, erythema and bruising. Only one study reported
moderate stimulation-related effects (dysesthetic pain in the right
upper and lower extremity), with no serious reactions leading to
RNS discontinuation.
• Clinical trials with appropriate sample sizes in the pediatric
population with drug-resistant epilepsy using RNS as adjunct
therapy to usual treatment are required to determine its
effectiveness in controlling the frequency, duration and intensity
of seizures, as well as the possible associated complications
during its use and impact on the quality of life of patients. The
results of clinical trials currently underway could determine the
effectiveness and safety of RNS systems in the pediatric
population with drug-resistant epilepsy in the near future.
Details
Project Status:
Completed
Year Published:
2022
URL for published report:
https://sescs.es/wp-content/uploads/2015/09/13_SESCS_RNS_Epilepsy_DEF_NIPO.pdf?x68814
English language abstract:
An English language summary is available
Publication Type:
Other
Country:
Spain
MeSH Terms
- Epilepsy
- Child
- Adolescent
- Implantable Neurostimulators
- Seizures
- Deep Brain Stimulation
- Drug Resistant Epilepsy
- Electric Stimulation Therapy
- Electrodes, Implanted
Contact
Organisation Name:
Canary Health Service
Contact Address:
Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife
Contact Name:
sescs@sescs.es
Contact Email:
sescs@sescs.es
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.