TRANscranial direct current stimulation for FOcal Refractory epilepsy in mitochondrial disease (TRANSFORM): delayed-start, randomised, double-blinded, placebo-controlled study

Transcranial Direct Current Stimulation for Focal Refractory Epilepsy in Mitochondrial Disease (TRANSFORM)

Study Overview

This study investigates the effectiveness of Transcranial DC Stimulation (tDCS) for treating focal epilepsy in patients with mitochondrial disease. Focal epilepsy is common in these patients and can be hard to treat with medications, leading to serious conditions like refractory focal status epilepticus.

Study Design

We conducted a double-blinded, sham-controlled study, which is the first of its kind for this condition. Participants aged 2 years and older with a confirmed mitochondrial disease diagnosis and drug-resistant focal epilepsy will be included. We aim to treat 30 episodes of focal status epilepticus over a maximum of 14 days.

Intervention Details

Participants in the early start group will receive tDCS from day 1, while those in the delayed start group will receive a placebo until day 3. Our main goal is to see a reduction of over 50% in seizure frequency compared to the baseline. We will also monitor brain changes through MRI and EEG.

Potential Impact

If the results show that tDCS is effective, it could become a standard treatment for focal seizures in patients with mitochondrial disease.

Clinical Trials Registration

Registered under ISRCTN: 18,241,112 on 16/11/2021.

Importance of Clinical Trials

Clinical trials are essential for developing safe and effective treatments. Our AI-driven platform, DocSym, helps integrate clinical protocols and research into a user-friendly resource for healthcare providers.

Streamlining Healthcare

In today’s healthcare landscape, efficiency is key. Our mobile apps assist with scheduling, treatment monitoring, and telemedicine, enhancing patient care and expanding digital services.

Improving Patient Outcomes

By leveraging AI, clinics can improve workflows and patient outcomes while reducing reliance on paper processes. Discover more about our solutions at aidevmd.com.

AI Products for Business or Try Custom Development

AI Sales Bot

Welcome AI Sales Bot, your 24/7 teammate! Engaging customers in natural language across all channels and learning from your materials, it’s a step towards efficient, enriched customer interactions and sales

AI Document Assistant

Unlock insights and drive decisions with our AI Insights Suite. Indexing your documents and data, it provides smart, AI-driven decision support, enhancing your productivity and decision-making.

AI Customer Support

Upgrade your support with our AI Assistant, reducing response times and personalizing interactions by analyzing documents and past engagements. Boost your team and customer satisfaction

AI Scrum Bot

Enhance agile management with our AI Scrum Bot, it helps to organize retrospectives. It answers queries and boosts collaboration and efficiency in your scrum processes.