50
Participants
Start Date
December 31, 2013
Primary Completion Date
December 31, 2015
Study Completion Date
July 31, 2016
Stimulation of the trigeminal nerve (active stimulation)
"Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.~After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.~Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.~The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks. the duration of the open label trial will be more 24 weeks."
Placebo stimulation of the trigeminal nerve (placebo)
"Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.~After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.~Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.~The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks."
Hospital do Coracao, São Paulo
Hospital do Coracao
OTHER