TDCS for focal refractory epilepsy in mitochondrial disease (POLG)
Research type
Research Study
Full title
TRANscranial direct current Stimulation for FOcal Refractory epilepsy in Mitochondrial disease (TRANSFORM): delayed-start, randomised, double-blinded, placebo-controlled trial
IRAS ID
281536
Contact name
Robert Mc Farland
Contact email
Sponsor organisation
Newcastle Joint Research Office
ISRCTN Number
ISRCTN18241112
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Focal epilepsy is common in children and adults with mitochondrial disease. Seizures in these patients may not respond to multiple anti-epileptic drugs (refractory) and can lead to serious neurological consequences with poor prognosis. We have successfully used transcranial direct current (brain) stimulation (tDCS) that delivers a low current to calm these seizure activities. In this delayed-start, randomised, double-blinded, placebo-controlled trial, one group of participants will receive tDCS treatment immediately (early-start) while the other group (delayed-start) will have non-active (sham) treatment for the first two days. The treatment has a gradual effect with repeated applications. We expect the early-start group to see improvement in their seizures before the delayed-start group.
Our goal is to assess the efficacy of tDCS as an adjunctive treatment in reducing the number of focal epileptic seizures experienced by children and adults with genetically-confirmed mitochondrial disease.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0137
Date of REC Opinion
16 Jul 2021
REC opinion
Favourable Opinion