Electrical brain stimulation with transcranial direct current (tDCS) to treat focal epilepsy in patients with mitochondrial disease (POLG mutation)

Not Applicable

• Conditions: Focal refractory epilepsy in mitochondrial disease; Nervous System Diseases

• Registration Number: ISRCTN18241112
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-16
• Last Update Posted: 11 September 2023
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure frequency (number and duration of seizures, jerks/min according to European Medicines Agency guidelines). This is measured by daily reporting from specialists, nurses, research staff, relatives, and carers by seizure diary and video monitoring from day 0 to day 14.

Secondary Outcome Measures

Name	Time	Method
1. Seizure freedom (based on daily seizure diary for max 14 days, video monitoring, and end-of study EEG).<br>2. Adverse events measured using case report forms throughout the study.<br>3. Assessment of side effects by daily seizure diary.<br>4. Neurophysiology and/or neuroradiology findings: MRI, CT and EEG if obtained before study inclusion as part of standard care to localise the seizure are compared to measurements after the treatment. We obtain an end of study EEG and also ask permission for the patient’s clinical information (e.g. MRI/CT) obtained before and up to 6 months after the study to evaluate the treatment effects<br>5. Quality of life assessed by validated participant and carer(s) questionnaires at baseline and after 14 days