Epilepsy Study
Safety and therapeutic measures of Transcranial Cathodal Direct Current Stimulation (tDCS) in patients with Refractory Focal Epilepsy
This study is being conducted to evaluate whether 10 daily sessions of transcranial direct current stimulation (tDCS) can help to reduce the frequency of seizures (the number of seizures in a given period of time) in both adults and children with refractory focal epilepsy (epilepsy that cannot be well controlled by seizure medication).
During the study, patients will be asked to record seizures in a seizure diary for 12 weeks prior to study treatment. If the research investigator agrees to your participation in the treatment phase of the study, you will be randomly placed into either the active treatment group or the control group. If placed in the active treatment group, you will receive tDCS that is specifically designed to treat your epilepsy.
What is Transcranial Direct Current Stimulation (tDCS)?
Transcranial direct current stimulation (tDCS) is a non-surgical, non-invasive therapy that uses a medical device worn on your head to deliver mild electrical currents to your scalp. The use of tDCS in this study is investigational, which means that it is not approved by the FDA for the treatment of focal epilepsy.
The most common side effects that you may expect from taking part in this research include sensations under the electrodes such as tingling or itching, mild pain, discomfort or burning, skin irritation, or redness. These sensations usually go away shortly after the start of stimulation.
Are you eligible?
MAKE SURE TO CHECK WITH YOUR PHYSICIAN FOR ELIGIBILITY
AGE
Are you over 9 years old?
DIAGNOSIS
Are you clinically diagnosed with focal epilepsy- not responsive to drug therapy?
If you responded yes to these questions you might be eligible to participate in the study.
Study Details
A multi-step process
Randomized study- 50% chance to receive the stimulation treatment.
There is no cost to participate. You or your insurance will not be billed for any of the study assessments.
Reimbursement for travel or parking expenses and a fee for the completion of the study seizure diary related to your participation are available.
You do not have to change any of the current medications you are taking for your condition in order to participate in the study.
Clinical Development
How many sessions?
Each patient will receive 10 daily sessions of tDCS over two weeks (10 consecutive weekdays).
Evolution
Following the 2-week treatment period, there will be 10 weeks of additional evaluation.
Participant sites:
United States, California
Keck Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Charles Liu, M.D 818-284-1626 cliu@usc.edu
Contact: Joanne Gibbons, CRC (818) 284-1626 joannegi@med.usc.edu
United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92354
Contact: Danilo Vitorovic, M.D 909-558-2037 dvitorovic@llu.edu
Contact: Julie Lacanlale, CRC (909) 558-2037 JLacanlale@llu.edu
United States, Florida
University of Florida Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Katherine Zarroli, M.D 904-244-9856 katherine.zarroli@jax.ufl.edu
Contact: Yasmeen Shabbir, CRC 904-244-9856 yasmeen.shabbir@jax.ufl.edu
United States, Massachusetts
Boston Children's Hospital Comprehensive Epilepsy Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Alexander Rotenberg, M.D 617-355-7970 Alexander.Rotenberg@childrens.harvard.edu
Contact: Paul MacMullin, CRC (617) 355-7970 Paul.MacMullin@childrens.harvard.edu
Beth Israel Deconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mo Shafi, M.D mshafi@bidmc.harvard.edu
Contact: Lucia Leblanc Perez, CRC 617-632-8934 lleblan1@bidmc.harvard.edu
United States, Maryland
LifeBridge Health Recruiting
Baltimore, Maryland, United States, 21215
Contact: Arash Foroughi, M.D 410-601-0960 aforough@lifebridgehealth.org
Contact: Seanne Facho, CRC 410.601.0960 sfacho@lifebridgehealth.org
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brian Lundstrom, M.D 507-293-1120 lundstrom.brian@mayo.edu
Contact: Carey Huebert, CRC 507-293-1120 Huebert.Carey@mayo.edu
United States, Missouri
Washington University Medical Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robert Hogan, M.D 314-362-7871 hoganre@wustl.edu
Contact: Patty Schaefer, CRC 314-362-7871 patty.schaefer@wustl.edu
United States, New Jersey
Robert Wood Johnson Medical School (Rutgers) Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Stephen Wong, M.D 732-235-7342 ac1659@rwjms.rutgers.edu
Contact: Asha Cilly, CRC 732-235-7342 ac1659@rwjms.rutgers.edu
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Trent Tollefson, M.D 585-341-7500 Trenton_Tollefson@urmc.rochester.edu
Contact: Cate Concannon, CRC 585-275-0404 Cathleen_Concannon@urmc.rochester.edu
United States, Pennsylvania
University of Pennsylvania (Penn Epilepsy) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mindy Ganguly, M.D 215-662-7227 taneeta.ganguly@pennmedicine.upenn.edu
Contact: Melissa Johnston Esparza, CRC (215) 662-7227 melissa.johnstonesparza@pennmedicine.upenn.edu
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Abou-Khalil Bassel, M.D 615-936-0209 bassel.abou-khalil@vumc.org
Contact: Melissa Osborn, CRC 615-936-0209 melissa.osborn@vumc.org
United States, Utah
University Of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Amir Arain, M.D Amir.Arain@hsc.utah.edu
Contact: Laura Beeler, CRC (801) 585-9266 laura.beeler@hsc.utah.edu
Spain, Barcelona
Hospital Sant Joan de Déu
Spain, Barcelona
Hospital Universitari Vall d'Hebron
Spain, Barcelona
Hospital del Mar
Spain, Barcelona
Hospital Clinic
Spain, Madrid
Hospital Niño Jesus
Spain, Madrid
Hospital Ruber Internacional
Spain, Huelva
CEO Centro Neurología Avanzada
Spain, Málaga
Hospital Regional Universitario de Málaga
France, Lyon
Hospices Civils De Lyon
France, Marseille
CHU de Marseille - Hôpital de la Timone
Belgium, Bruxelles
Cliniques Universitaires Saint Luc
Belgium, Ghent
Ghent University Hosp. Dpt Neurology
Germany, Freiburg
University Hospital Freiburg
Germany, Munich
Ludwig-Maximilians University Munich
Germany, Berlin
Charité - Pediatric Neurology
If you have further questions, please refer to this study by its ClinicalTrials.gov identifier
(NCT number): NCT04770337