- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02824445
To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder
28 décembre 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
13
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73145
- 72d Medical Group
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 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)
- PCL-M score > 45
- Age between 18 and 55 years (at day of informed consent)
- Willing and able to adhere to the treatment schedule and all required study visits.
- Must be clinically stable for at least 30 days on or off any PTSD medication before the trial treatment
Exclusion Criteria:
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
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
- Abnormalities that indicate risk of seizure, i.e., focal or general slowing or spikes during EEG recording
- Any type of rTMS treatment within 3 months prior to the screening visit
- Currently under antipsychotic medication treatment
- 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
- 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
- Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning
- Any condition which in the judgment of the investigator would prevent the subject from completion of the study
- Inability to acquire a clinically satisfactory EEG/ECG on a routine basis
- Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation
- Pregnant or breastfeeding women
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur factice: 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.
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Autres noms:
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Expérimental: 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.
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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.
Délai: At the end of week of 4 and 8.
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The change of PCL-M and CPFQ scores from baseline and at weeks of 4 and 8 are assessed.
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At the end of week of 4 and 8.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mai 2015
Achèvement primaire (Réel)
28 mai 2018
Achèvement de l'étude (Réel)
28 mai 2018
Dates d'inscription aux études
Première soumission
23 juin 2016
Première soumission répondant aux critères de contrôle qualité
1 juillet 2016
Première publication (Estimation)
6 juillet 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 décembre 2019
Dernière vérification
1 décembre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FWH20150038H
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
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