TRANscranial direct current Stimulation for FOcal Refractory epilepsy in Mitochondrial disease (TRANSFORM): delayed-start, randomised, double-blinded, placebo-controlled trial

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2021年11月16日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•1. Adult and paediatric patients aged >=2 years
•2. Patients with a genetically confirmed diagnosis of mitochondrial disease
•3. Drug-resistant focal epilepsy defined by the International League Against Epilepsy (ILAE) as failure of two antiepileptic drugs to achieve sustained seizure freedom
•4. Anatomically relevant changes related to focal seizures defined by neuroimaging and/or scalp EEG
•5. Able to undergo all study assessments and investigations in the opinion of the recruiting investigator in agreement with the patient/parents/legal guardian
•6. For patients under the age of 16 years, parental consent must be provided

•1. Paediatric patients aged <2 years
•2. Patients with metallic implants (pins, stents, metal clips etc.) or electronic implants (e.g., pacemaker, defibrillator, cochlear implants, and other forms of stimulator) that typically preclude MRI scanning and/or tDCS treatment.
•3. Patients with other co-existing epileptic comorbidity e.g., brain tumour, traumatic brain injury, cortical dysplasia
•4. Patients with other known uncontrolled medical problems that, in the opinion of the investigator, would preclude participation in the study.
•5. Inability of patient/legal guardian to provide informed consent.
•*MRI scanning is regularly done as part of the standard clinical care of our target patient group. This study relies on the MRI results in order to determine the target for tDCS stimulation as part of the regular clinical care. No MRI exams will be performed as a part of this study.

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust