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(904) 244-0411

Safety and Therapeutic Measures of Transcranial Cathodal Direct Current Stimulation (tDCS) in Patients with Refractory Focal Epilepsy

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
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Description

The purpose of this research is to learn more about Transcranial Cathodal Direct Current Stimulation (tDCS) and to see if it can help reduce the frequency of seizures in both adults and children with refractory focal epilepsy (epilepsy that cannot be well controlled by anti-seizure medication).

The use of tDCS is investigational in this study, which means that it is not approved by the FDA for the treatment of refractory focal epilepsy. Prior research suggests that daily tDCS may reduce the frequency of seizures in some patients with refractory focal epilepsy, although in some cases an increase in seizure frequency has also been observed. These changes may be due to tDCS decreasing the over-reaction of the region of your brain that your doctor believes causes your seizures.

There are a total of 14 visits, some of which may be conducted remotely. We expect that your involvement in this research will last approximately 6 months.

After you sign a consent document and agree to participate in this study, the following evaluations will be done:

  1. A review of your medical history and medications. This includes a review of your seizure history and treatment.

  2. We will ask you for a copy of a recent EEG and MRI. If your MRI is not suitable for the study, the study doctor may ask you to have another MRI.

  3. A urine pregnancy test if you are female and able to have children.

  4. A physical and neurological exam.  You will be financially compensated to cover travel and hotel expenses. The study staff is available via phone and email to answer questions if you are interested in participating in the trial or would like to learn more about the study.

Details

Protocol number WIRB20212642

Eligibility

Main inclusion criteria are:

  • 9 years or older
  • Focal epilepsy-not responsive to drug therapy  

Lead researchers

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.