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Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Research Question:
Can transcranial direct current stimulation (tDCS) help to reduce the frequency of seizures in adults and children with refractory focal epilepsy (epilepsy that cannot be well controlled by seizure medication)?

Basic Study Information

Purpose:
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be assigned to receive treatment with either STARTSTIM or a sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

Location: University of Rochester
Study Reference #: 00006545

Lead Researcher (Principal Investigator)

Lead Researcher:  Trenton Tollefson

Study Contact Information

Study Coordinator: Noreen Connolly
Phone: (585) 275-0589
Email: Noreen_Connolly@urmc.rochester.edu

Additional Study Details

Study Details:
For Vists #2 through #11 you will need to come to URMC every day, Monday through Friday, for two weeks in a row for about 1.5 hours.

Number of Visits:  More than 10
Parking:  Free
Transportation Coverage:  Yes
Reimbursement:  Yes

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