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During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Search Results 1-5 of 5 for Deep brain stimulation

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  • Study status: Open/Status Unknown
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  1. A Study to Evaluate fMRI of Active Deep Brain Stimulation in Epilepsy

    Jacksonville, FL

    A Study to Evaluate fMRI of Active Deep Brain Stimulation in Epilepsy

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to to use functional imaging to study the mechanisms of anterior thalamic nucleus (ANT) Deep Brain Stimulation (DBS).

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Jacksonville, Fla.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Jacksonville, Florida: 18-010321

    • NCT ID:

      NCT03870308

    • Sponsor Protocol Number:

      18-010321

  2. High Frequency Oscillations in Neurologic Disease

    Rochester, MN

    High Frequency Oscillations in Neurologic Disease

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      I
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS). Study participants will undergo DBS in the same way as is usually done but will receive this newer battery with ability to record brain signals.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 13-002360

    • NCT ID:

      NCT02235792

    • Sponsor Protocol Number:

      13-002360

  3. Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy

    Rochester, MN

    Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to track seizure occurrence, seizure probability, behavioral state, cognition, and mood using an implantable brain sensing and stimulation device (Medtronic RC+S Summit) coupled to an external, handheld, patient assistant device (PAD) with capability for patient interaction (patient data input). The system (RC+S & PAD) provides intracranial EEG (iEEG) sensing, electrical brain stimulation, and machine learning algorithms running on the RC+S and PAD that will be coupled with electrical brain stimulation (EBS) to prevent seizures and improve quality of life in patients with epilepsy

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 18-005483

    • NCT ID:

      NCT03946618

    • Sponsor Protocol Number:

      18-005483

  4. A Study to Establish a Registry of Deep Brain Stimulation with the VERCISE™ System

    Jacksonville, FL

    A Study to Establish a Registry of Deep Brain Stimulation with the VERCISE™ System

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to document characteristics of real-world outcomes for Boston Scientific Corporation’s commercially approved Vercise™ System for Deep Brain Stimulation (DBS) when used according to the applicable Directions for Use.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Jacksonville, Fla.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Jacksonville, Florida: 19-002804

    • Sponsor Protocol Number:

      A4069

  5. Deep Brain Stimulation for Orthostatic Tremor

    Rochester, MN

    Deep Brain Stimulation for Orthostatic Tremor

    • Location:

      Observational

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to report a case series of patients with orthostatic tremor (OT) who underwent Deep Brain Stimulation (DBS) at Mayo Clinic and to follow-up those patients with telephone questionnaires to assess long-term response to DBS.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 15-004653

    • Sponsor Protocol Number:

      15-004653
.

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