Efficacy of low frequency repetitive transcranial magnetic stimulation (rTMS) therapy among children with focal onset drug refractory epilepsy – A single arm interventional study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- DGAFMS
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the proportion of children and adolescents between 4-18 years, with drug resistant epilepsy, who achieve 50% seizure reduction at 12 weeks follow up compared to baseline.
研究概览
简要总结
Upto one third of patients with epilepsy progress to drug resistant epilepsy(DRE). Current treatment options for DRE include ketogenic diet, epileptic surgeryand invasive brain stimulation technique like vagal nerve stimulation whichrequires expertise, cost and not effective for all cases of drug refractoryfocal epilepsy. rTMS remains one of the safe non invasive technique forrefractory focal epilepsy. rTMS is one potential optionwhich needs to be explored thoroughly. The limited Literature regardingtherapeutic potential of rTMS in refractory epilepsy is conflicting. Thepatient and disease characteristics which can predict successful outcome fromrTMS therapy is still elusive. No consensus exists onthe ideal TMS protocol which can achieve maximum long term efficacy in epilepsycontrol. None of the rTMS protocols used in literature have been subjected tomeasurement of change in cortical excitability induced by them. Though safetyand tolerability of rTMS in pediatric population is well documented, nopediatric studies are available till date. This study will help to validate theprotocol and effectiveness of rTMS in drug resistant epilepsy in children andadolescent between 4-18 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 4.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children and adolescents of either sex aged 4 -18 years diagnosed with drug refractory epilepsy as per with ILAE
- •Drug refractory epilepsy will be defined as ≥ 1 seizure / week OR 4 seizures/month despite on ≥ 2 appropriately chosen and optimally prescribed antiepileptic drugs.
- •1.Duration of epilepsy for atleast 1 year 2.Seizures of single semiology 3.Majority (75%) of Interictal epileptiform discharges (SWI) arising over a single epileptogenic focus on sleep EEG 4.Parents/ guardians willing to follow the treatment protocol of daily sessions for 10 days in 2 week with Sunday off and hospital follow up at 12 weeks of total study period.
排除标准
- •1.Hemispheric epilepsy syndromes such as Rasmeussen’s encephalitis, Hemiconvulsion-hemiplegia epilepsy syndrome or Hemimegalancephaly.
- •2.Diagnosed epileptic encephalopathy other than focal ESES (Electrical status epilepticus in sleep) 3.Diagnosed progressive neurological disorder
- •Previous epilepsy surgery or vagal nerve stimulation insertion.
- •5.Patient waitlisted for epilepsy surgery within 6 months 6.Presence of Metallic implants anywhere in the body.
结局指标
主要结局
To determine the proportion of children and adolescents between 4-18 years, with drug resistant epilepsy, who achieve 50% seizure reduction at 12 weeks follow up compared to baseline.
时间窗: At baseline | At 12 week post therapy
次要结局
- 1.To compare mean reduction in seizure frequency from baseline with low frequency rTMS therapy at follow up period of 12 weeks in children and adolescents aged 4-18 years with focal onset drug refractory epilepsy(2. To determine the proportion of children and adolescents between 4-18 years, with drug resistant focal epilepsy, who achieve 50% reduction in spike wave index in a 30 min sleep interictal video EEG at 12 weeks follow up.)