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To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder

28 de diciembre de 2019 actualizado por: Jianzhong Zhang, 72nd Medical Group, Tinker Air Force Base

A Pilot Study to Evaluate the Efficacy of EEG/ECG-guided Magnetic Resonant Therapy (MeRT) in War Veterans With Posttraumatic Stress Disorder (PTSD) at Tinker and MacDill Air Force Bases

After 13 years of war, PTSD has become pervasive in service members. Traditionally it is evaluated by PTSD Checklist Military Version (PCL-M) and treated with cognitive processing therapy, prolonged exposure therapy and medication management with limited success. Repetitive Transcranial Magnetic Stimulation (TMS) has shown efficacy for improving individual cognitive function in the past decades, both in healthy population and in patients with depression. TMS has been approved by the FDA in treatment of major depressive disorder and migraine headaches. Magnetic EEG guided Resonant Treatment (MeRT) is a form of individualized TMS based on member's EEG/ECG input. Investigators propose to use MeRT to treat veterans with war-related PTSD, a syndrome that includes depressive and anxious symptoms; it is likely that MeRT (namely TMS) will be beneficial and comparable to or better than the current FDA approved methods for treating PTSD.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

13

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73145
        • 72d Medical Group

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Have diagnosis of combat-related PTSD by DSM-V criteria, diagnosed via clinical interview by psychologist or psychiatrist (note: combat pilots of remotely piloted aircraft are included)
  2. PCL-M score > 45
  3. Age between 18 and 55 years (at day of informed consent)
  4. Willing and able to adhere to the treatment schedule and all required study visits.
  5. Must be clinically stable for at least 30 days on or off any PTSD medication before the trial treatment

Exclusion Criteria:

  1. Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):

    • History of open skull traumatic brain injury
    • History of clinically significant seizure disorder
  2. Individuals with a clinically defined neurological disorder including, but not limited to:

    • Any condition likely to be associated with increased intracranial pressure
    • Space occupying brain lesion
    • History of cerebrovascular accident
    • Cerebral aneurysm
  3. Abnormalities that indicate risk of seizure, i.e., focal or general slowing or spikes during EEG recording
  4. Any type of rTMS treatment within 3 months prior to the screening visit
  5. Currently under antipsychotic medication treatment
  6. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
  7. Clinically significant abnormality or clinically significant unstable medical condition that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results
  8. Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning
  9. Any condition which in the judgment of the investigator would prevent the subject from completion of the study
  10. Inability to acquire a clinically satisfactory EEG/ECG on a routine basis
  11. Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation
  12. Pregnant or breastfeeding women

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador falso: Sham
The double-blind is used during the first 2 weeks. From week 3 and on, the study becomes open label. Subjects in Group I (active MeRT treatment group) will continue receive active MeRT treatment for W3/4; subjects in Group II (placebo/sham group) will receive active MeRT treatment from W3 to W6 for 4 weeks. All subjects will receive 4 weeks active MeRT treatment. The study ends in 8th wk. The data collection points are baseline, weeks of 2, 4, 6, and 8. The data from weeks 1-2 (Phase I) will be utilized to analyze the safety and any effect of MRT procedure may have over placebo. The data from weeks 3 on (Phase II) will be used to address if any benefit of longer MeRT treatment (4 vs 2 weeks). The study design offers both groups 4 weeks of the experimental therapy in a row. This will provide potentially equal benefit to those participants assuming that MeRT helps to improve PTSD symptoms.
Otros nombres:
  • EEG-GUIDED MAGNETIC RESONANT THERAPY (MeRT)
Experimental: Treatment
The double-blind is used during the first 2 weeks. From week 3 and on, the study becomes open label. Subjects in Group I (active MeRT treatment group) will continue receive active MeRT treatment for W3/4; subjects in Group II (placebo/sham group) will receive active MeRT treatment from W3 to W6 for 4 weeks. All subjects will receive 4 weeks active MeRT treatment. The study ends in 8th wk. The data collection points are baseline, weeks of 2, 4, 6, and 8. The data from weeks 1-2 (Phase I) will be utilized to analyze the safety and any effect of MRT procedure may have over placebo. The data from weeks 3 on (Phase II) will be used to address if any benefit of longer MeRT treatment (4 vs 2 weeks). The study design offers both groups 4 weeks of the experimental therapy in a row. This will provide potentially equal benefit to those participants assuming that MeRT helps to improve PTSD symptoms.
Otros nombres:
  • EEG-GUIDED MAGNETIC RESONANT THERAPY (MeRT)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The outcome will be measured by PTSD checklist -- military version (PCL-M) scoring criteria for PTSD. The outcome is measured additionally by Cognitive and Physical Functioning Questionnaire (CPFQ) for cognitive function improvement among the subjects.
Periodo de tiempo: At the end of week of 4 and 8.
The change of PCL-M and CPFQ scores from baseline and at weeks of 4 and 8 are assessed.
At the end of week of 4 and 8.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2015

Finalización primaria (Actual)

28 de mayo de 2018

Finalización del estudio (Actual)

28 de mayo de 2018

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2016

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2016

Publicado por primera vez (Estimar)

6 de julio de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de enero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

28 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • FWH20150038H

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre individualized Transcranial Magnetic Stimulation

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