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

Primary Purpose

Refractory Epilepsy, Focal Seizure, Seizures, Focal

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
STARSTIM device
Sham Device
Sponsored by
Neuroelectrics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring Epilepsy, Focal seizure, Seizure

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 9 years old or older
  2. Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures.

    Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization.

  3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years.
  4. Seizure frequency ≥3 per month, over the past year.
  5. Currently on ≥1 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to baseline visit in the study and no planned dose changes during the trial. Changes after baseline visit are permitted only if clinically necessary.
  6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR sequences, performed within past 3 years and more recently than any craniotomy or skull burr hole procedure.
  7. Seizure focus that allows design of an appropriate stimulation montage. Note: Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identification of the border of the seizure focus can be approximate (+/- 2 gyri).
  8. Available seizure history and supporting data
  9. All female study subjects of child-bearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of <=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective).
  10. Written informed consent obtained from study subject or subject's legal representative and ability for study subject to comply with the requirements of the study.
  11. Assent from pediatric subjects when appropriate.

Exclusion Criteria:

  1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data.
  2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is defined as a cortical region confined to one hemisphere and either one lobe or on a junction of two adjacent lobes from which seizures arise , as documented by scalp or intracranial EEG, that is either supported or not refuted by MRI, and either supported or not refuted by clinical semiology). If the interictal EEG is normal, a seizure focus may be identified by the combination of structural findings on MRI and clinical signs/symptoms associated with the subject's seizures.
  3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal
  4. Seizure focus is hemispheric or poorly defined
  5. History of psychogenic nonepileptic seizures in past 2 years, or physiologic nonepileptic seizures and non-epileptogenic events, including suspicion for or a significant history of syncope, and any non-epileptic events must be clearly differentiable from subject's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the subject's PNES compared to their epileptic seizures.
  6. Seizures of generalized onset
  7. Status epilepticus in the last 12 months
  8. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the subject's ability to complete a study of 24 weeks duration
  9. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the subject or the integrity of the data.
  10. Damaged skin on scalp that may interfere with tDCS stimulation.
  11. Pregnant or unwilling to practice birth control during participation in the study.
  12. Nursing mothers.
  13. Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). Note: Vagus nerve stimulator (VNS) is allowable if the device is in MR Mode (e.g. switched off) during tDCS stimulation and the VNS device is MR conditional.
  14. Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
  15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use of any illicit substance.

Sites / Locations

  • Barrow Neurological Institute, St. Joseph's Hospital & Medical CenterRecruiting
  • Loma Linda University HealthRecruiting
  • Keck Medicine of USCRecruiting
  • Children's Hospital of Orange CountyRecruiting
  • University of Florida JacksonvilleRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Sinai HospitalRecruiting
  • Johns Hopkins UniversityRecruiting
  • Boston Children's Hospital Comprehensive Epilepsy CenterRecruiting
  • Beth Israel Deconess Medical CenterRecruiting
  • Mayo ClinicRecruiting
  • Washington University Medical CenterRecruiting
  • Robert Wood Johnson Medical School (Rutgers)Recruiting
  • University of RochesterRecruiting
  • University of Pennsylvania (Penn Epilepsy)Recruiting
  • Vanderbilt University Medical CenterRecruiting
  • University Of UtahRecruiting
  • Seattle Children's Hospital, University of WashingtonRecruiting
  • Cliniques Universitaires Saint LucRecruiting
  • Ghent University Hosp. Dpt NeurologyRecruiting
  • Hospices Civils De LyonRecruiting
  • CHU de Marseille - Hôpital de la TimoneRecruiting
  • Hospital ClínicRecruiting
  • Hospital Del MarRecruiting
  • Hospital Sant Joan de DéuRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • CEO Centro Neurología AvanzadaRecruiting
  • Hospital Niño JesusRecruiting
  • Hospital Ruber InternacionalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham treatment

STARSTIM device treatment

Arm Description

Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.

Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.

Outcomes

Primary Outcome Measures

The difference between active treatment and sham treatment in the percentage change

Secondary Outcome Measures

The proportion of subjects who are responders (defined as subjects with a 50% or greater reduction in seizure frequency

Full Information

First Posted
February 22, 2021
Last Updated
July 21, 2023
Sponsor
Neuroelectrics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04770337
Brief Title
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
Official Title
STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuroelectrics Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief Summary
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 treated with STARTSTIM or 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.
Detailed Description
Study design is an evaluation of the STARSTIM device (tDCS) in subjects over 9 years of age, diagnosed with epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures. Seizure diaries will be collected for 12 weeks to establish a rate of seizure for each subject prior to treatment. Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment. Treatment will be done daily at the investigator's site for 10 days. A Seizure Diary will be maintained through the course of the treatment and the follow up period. Subjects will have 3 follow up visits to evaluate their seizure rate, adverse events, medications and quality of life. A Data Safety Monitoring Board will be utilized to evaluate safety events through study milestones. Seizure frequency rates pre, during and post treatment will be evaluated for both the active and sham treatment arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy, Focal Seizure, Seizures, Focal, Seizures, Epilepsy in Children, Epilepsy, Epilepsy, Tonic-Clonic
Keywords
Epilepsy, Focal seizure, Seizure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multiple site, randomized, double blinded parallel-group controlled study
Masking
ParticipantInvestigator
Masking Description
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment.
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Arm Title
STARSTIM device treatment
Arm Type
Experimental
Arm Description
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Intervention Type
Device
Intervention Name(s)
STARSTIM device
Intervention Description
Cathodal Transcranial Direct Current Stimulation (tDCS). Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp
Primary Outcome Measure Information:
Title
The difference between active treatment and sham treatment in the percentage change
Time Frame
from baseline in seizures over the 12 weeks following initiation of treatment.
Secondary Outcome Measure Information:
Title
The proportion of subjects who are responders (defined as subjects with a 50% or greater reduction in seizure frequency
Time Frame
from baseline to week 12 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 9 years old or older Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures. Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years. Seizure frequency ≥3 per month, over the past year. Currently on ≥1 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to baseline visit in the study and no planned dose changes during the trial. Changes after baseline visit are permitted only if clinically necessary. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR sequences, performed within past 3 years and more recently than any craniotomy or skull burr hole procedure. Seizure focus that allows design of an appropriate stimulation montage. Note: Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identification of the border of the seizure focus can be approximate (+/- 2 gyri). Available seizure history and supporting data All female study subjects of child-bearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of <=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective). Written informed consent obtained from study subject or subject's legal representative and ability for study subject to comply with the requirements of the study. Assent from pediatric subjects when appropriate. Exclusion Criteria: Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is defined as a cortical region confined to one hemisphere and either one lobe or on a junction of two adjacent lobes from which seizures arise , as documented by scalp or intracranial EEG, that is either supported or not refuted by MRI, and either supported or not refuted by clinical semiology). If the interictal EEG is normal, a seizure focus may be identified by the combination of structural findings on MRI and clinical signs/symptoms associated with the subject's seizures. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal Seizure focus is hemispheric or poorly defined History of psychogenic nonepileptic seizures in past 2 years, or physiologic nonepileptic seizures and non-epileptogenic events, including suspicion for or a significant history of syncope, and any non-epileptic events must be clearly differentiable from subject's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the subject's PNES compared to their epileptic seizures. Seizures of generalized onset Status epilepticus in the last 12 months Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the subject's ability to complete a study of 24 weeks duration Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the subject or the integrity of the data. Damaged skin on scalp that may interfere with tDCS stimulation. Pregnant or unwilling to practice birth control during participation in the study. Nursing mothers. Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). Note: Vagus nerve stimulator (VNS) is allowable if the device is in MR Mode (e.g. switched off) during tDCS stimulation and the VNS device is MR conditional. Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use of any illicit substance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demi Thai, M.D
Phone
34 93 254 03 66
Email
demi.thai@neuroelectrics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thaïs Baleeiro, PhD
Phone
34 93 254 03 66
Email
thais.baleeiro@neuroelectrics.com
Facility Information:
Facility Name
Barrow Neurological Institute, St. Joseph's Hospital & Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Herman, M.D
First Name & Middle Initial & Last Name & Degree
Karuna Sehdev, SRC
Phone
602-406-7401
Email
karuna.sehdev@dignityhealth.org
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firas Bannout, M.D
First Name & Middle Initial & Last Name & Degree
David Borg, CRC
Phone
(909) 558-2037
Email
dborg@llu.edu
Facility Name
Keck Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Liu, M.D
First Name & Middle Initial & Last Name & Degree
Joanne Gibbons, CRC
Phone
(818) 284-1626
Email
joannegi@med.usc.edu
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Phillips, M.D
First Name & Middle Initial & Last Name & Degree
Charlotte Lynskey, SRC
Email
alorenzana@choc.org
Facility Name
University of Florida Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Zarroli, M.D
First Name & Middle Initial & Last Name & Degree
Yasmeen Shabbir, CRC
Phone
904-244-9856
Email
yasmeen.shabbir@jax.ufl.edu
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faisal Ibrahim, M.D
Email
fibrahim44@siumed.edu
Facility Name
Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arash Foroughi, M.D
First Name & Middle Initial & Last Name & Degree
Seanne Facho, CRC
Phone
410.601.0960
Email
sfacho@lifebridgehealth.org
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Krauss, M.D
Email
gkrauss@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Pam Coe, SRC
Phone
410-502-5570
Email
pcoe@jhmi.edu
Facility Name
Boston Children's Hospital Comprehensive Epilepsy Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Rotenberg, M.D
First Name & Middle Initial & Last Name & Degree
Paul MacMullin, CRC
Phone
(617) 355-7970
Email
Paul.MacMullin@childrens.harvard.edu
Facility Name
Beth Israel Deconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mo Shafi, M.D
First Name & Middle Initial & Last Name & Degree
Lucia Leblanc Perez, CRC
Phone
617-632-8934
Email
lleblan1@bidmc.harvard.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Lundstrom, M.D
First Name & Middle Initial & Last Name & Degree
Carey Huebert, CRC
Phone
507-293-1120
Email
Huebert.Carey@mayo.edu
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hogan, M.D
First Name & Middle Initial & Last Name & Degree
Patty Schaefer, CRC
Phone
314-362-7871
Email
patty.schaefer@wustl.edu
Facility Name
Robert Wood Johnson Medical School (Rutgers)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ram Mani, M.D
First Name & Middle Initial & Last Name & Degree
Asha Cilly, CRC
Phone
732-235-7342
Email
ac1659@rwjms.rutgers.edu
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trent Tollefson, M.D
First Name & Middle Initial & Last Name & Degree
Noreen L Connolly, CRC
Phone
(585) 275-0589
Email
noreen_connolly@urmc.rochester.edu
Facility Name
University of Pennsylvania (Penn Epilepsy)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindy Ganguly, M.D
First Name & Middle Initial & Last Name & Degree
Melissa Johnston Esparza, CRC
Phone
(215) 662-7227
Email
melissa.johnstonesparza@pennmedicine.upenn.edu
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abou-Khalil Bassel, M.D
First Name & Middle Initial & Last Name & Degree
Melissa Osborn, CRC
Phone
615-936-0209
Email
melissa.osborn@vumc.org
Facility Name
University Of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Arain, M.D
First Name & Middle Initial & Last Name & Degree
Laura Beeler, CRC
Phone
(801) 585-9266
Email
laura.beeler@hsc.utah.edu
Facility Name
Seattle Children's Hospital, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuhua Bozarth, M.D
First Name & Middle Initial & Last Name & Degree
Jackie Lee-Eng, CRC
Phone
12069872078
Email
jacqueline.lee-eng@seattlechildrens.org
Facility Name
Cliniques Universitaires Saint Luc
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riëm El Tahry, M.D
Email
riem.eltahryi@uclouvain.be
Facility Name
Ghent University Hosp. Dpt Neurology
City
Ghent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Boon, M.D
Email
paul.boon@ugent.be
Facility Name
Hospices Civils De Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Rheims, M.D
Email
sylvain.rheims@chu-lyon.fr
Facility Name
CHU de Marseille - Hôpital de la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Bartolomei, M.D
Email
Fabrice.Bartolomei@Ap-Hm.Fr
Facility Name
Hospital Clínic
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mar Carreño, M.D
Email
MCARRENO@clinic.cat
Facility Name
Hospital Del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Rocamora, M.D
Email
rrocamora@parcdesalutmar.cat
Facility Name
Hospital Sant Joan de Déu
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Climent, M.D
Email
mariaalejandra.climent@sjd.es
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Toledo, M.D
Email
Mtoledo@Vhebron.Net
Facility Name
CEO Centro Neurología Avanzada
City
Huelva
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Jesus Rodriguez Uranga, M.D
Email
uranganeuro@gmail.com
Facility Name
Hospital Niño Jesus
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Soto Insuga, M.D
Email
vsoto@salud.madrid.org
Facility Name
Hospital Ruber Internacional
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Gil Nagel, M.D
Email
agnagel@ruberinternacional.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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