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  • A Prospective Study To Evaluate The Use Of The Minder Device To Aid In Developing A Treatment Plan After Inconclusive Prolonged EEG In Patients With Epilepsy Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz. The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.

    Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.

    All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.
  • An Open-label, Long-term Study Evaluating RAP-219 In Adult Participants With Refractory Focal Onset Seizures Rochester, Minn.

    The purpose of this study is to evaluate the long-term safety of RAP-219 in participants with FOS.
  • Magnetoencephalography (MEG) Recordings to Interrogate the Brain: Clinically Indicated Rochester, Minn.

    The purpose of this study is to record brain activity using MEG in patients who are receiving MEG for clinical indications. MEG is a non-invasive neuroimaging technique that records the magnetic fields produced by neural activity. The MEG machine is completely passive, does not emit any electromagnetic activity, and does not have any known health related risks. The study aims to:

    1. Establish baseline MEG data across different age groups and medical conditions.
    2. Explore task-induced brain activity under different cognitive and sensory conditions.
    3. Investigate brain patters in patients receiving MEG for clinical indicaitons as ordered by their clinical team.
  • Optimizing Brain Stimulation Parameters (OBSP) Rochester, Minn.

    The purpose of this study is to test different stimulation parameter sets and evaluate patient outcomes.
  • Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy Rochester, Minn.

    The purpose of this study is determine the feasibility and efficacy of at-home Transcranial Direct Current Stimulation (tDCS) therapy for focal epilepsy.
  • Therapeutic and Side Effects of Invasive and Noninvasive Brain Stimulation Rochester, Minn.

    The overall purpose of this study is to evaluate the effectiveness and safety of brain stimulation techniques currently used for clinical patient care. To determine the likelihood of improvements in seizure frequency, neurological symptoms, and quality of life after treatment with brain stimulation in certain populations, as well as evaluate for any beneficial or deleterious side effects from these modalities. In addition, in instances were brain stimulation was used for diagnostic purposes such as with cortical mapping via TMS, outcomes will be compared to other results already available in the electronic medical record system (e.g., MRI).

     

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