To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder
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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stati Uniti, 73145
- 72d Medical Group
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Comparatore fittizio: 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.
|
Altri nomi:
|
|
Sperimentale: 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.
|
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- FWH20150038H
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .