Cranial Electrotherapy Stimulation Presentation to FDA Neurology - - PowerPoint PPT Presentation

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Cranial Electrotherapy Stimulation Presentation to FDA Neurology - - PowerPoint PPT Presentation

Nov 05, 2022 286 likes •641 views

Cranial Electrotherapy Stimulation Presentation to FDA Neurology Panel February, 2012 Subjects to be Covered 1. SUMMARY OF STUDIES 2. SUMMARY OF ADDICTION STUDIES 3. BLOOD PLASMA AND CSF STUDIES 4. MECHANISMS OF ACTION STUDIES 5. FOLLOW UP STUDIES

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Cranial Electrotherapy Stimulation Presentation to FDA Neurology Panel February, 2012

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  • 1. SUMMARY OF STUDIES
  • 2. SUMMARY OF ADDICTION STUDIES
  • 3. BLOOD PLASMA AND CSF STUDIES
  • 4. MECHANISMS OF ACTION STUDIES
  • 5. FOLLOW UP STUDIES
  • 6. A LOOK AT THE SAFETY OF CES
  • 7. RECOMMENDATIONS TO PANEL

Subjects to be Covered

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Summary of Studies

(Valid Scientific Evidence, 21 CFR 860.7 (C)(2))

  • 1. Well Controlled Investigations
  • a. Double Blind
  • b. Single Blind
  • c. Crossover Studies
  • 2. Studies and objective trials without

matched controls

  • a. Open Clinical Trials
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Summary of Addiction Studies

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Blood and CSF Studies

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Studies of the Mechanism of Action

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Follow Up Studies

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The Safety of CES

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In the treatment of more than 100,000 patients in the U.S. with CES there has never been a seizure reported. This was true even among known seizure patients such as withdrawing addicts and closed head injured subjects

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CES Patients Compared With London Norms for Non CES Treated Patients

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Comparable Patient Statistics Between London and Dallas CES Addiction Treatment Programs

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Recommendations

CES Be Classified in Class II for 1.Stress:

  • A. Depression
  • B. Anxiety
  • C. Insomnia
  • D. Cognitive Dysfunction
  • 2. Treatment of Addiction
  • 3. Adjunctive Treatment for Pain