N/A
Completed N=96
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
Stress Disorders, Post-Traumatic
Source: ClinicalTrials.gov NCT02268084 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase — 65.78; 65.25; -22.45; -14.75 score on a scale — p=.007
Summary
The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase |
65.78; 65.25; -22.45; -14.75 | .007 sig |
| SECONDARY Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase |
65.78; 65.25; -32.53; -30.9 | .326 |
| SECONDARY Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment |
10.85; 9.67; -4.66; -2.03 | — |
| SECONDARY Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment |
10.84; 9.67; -7.23; -5.39 | — |
| SECONDARY Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment |
24.23; 22.55; -11.33; -8.08 | — |
| SECONDARY Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment |
24.23; 22.55; -16.60; -15.43 | — |
| SECONDARY Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment |
18.89; 18.28; 3.11; 1.59; 16.18; 17.03 | — |
| SECONDARY Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment |
18.89; 18.28; 5.56; 4.83; 16.18; 17.02 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to adhere to the treatment schedule and all required study visits.
- Any non-Active Duty Military are included.
- PCL-M > 45
- Primary diagnosis of Posttraumatic Stress Disorder rendered by the Clinician Administered PTSD Scale (CAPS)
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.
- EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing or spikes during the 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.
- Active Duty Military are excluded.
Data sourced from ClinicalTrials.gov (NCT02268084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.