To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT02824445 |
Recruitment Status :
Terminated
(Due to permanant change of stations of investigators.)
First Posted : July 6, 2016
Last Update Posted : January 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Post-Traumatic Stress Disorders | Device: individualized Transcranial Magnetic Stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 2015 |
Actual Primary Completion Date : | May 28, 2018 |
Actual Study Completion Date : | May 28, 2018 |
Arm | Intervention/treatment |
---|---|
Sham Comparator: 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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Device: individualized Transcranial Magnetic Stimulation
Other Name: 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.
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Device: individualized Transcranial Magnetic Stimulation
Other Name: EEG-GUIDED MAGNETIC RESONANT THERAPY (MeRT) |
- 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. [ Time Frame: 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.
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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824445
United States, Oklahoma | |
72d Medical Group | |
Oklahoma City, Oklahoma, United States, 73145 |
Responsible Party: | Jianzhong Zhang, Chief, Aeromedical Services, 72nd Medical Group, Tinker Air Force Base |
ClinicalTrials.gov Identifier: | NCT02824445 |
Other Study ID Numbers: |
FWH20150038H |
First Posted: | July 6, 2016 Key Record Dates |
Last Update Posted: | January 2, 2020 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |