Clinical trial NCT02268084: Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
Official title: A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Treatment Efficacy of EEG/ECD-Guided Magnetic Resonant Therapy in Combat Veterans With Post-Traumatic Stress Disorder (PTSD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
TMS
EEG
Lead sponsor: Wave Neuroscience
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sham controlled
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.

Detailed description: This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy (MRT) in combat veterans with Posttraumatic Stress Disorder. A total of 2004 subjects will be treated in two phases: double-blind and open label.

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.

Primary outcomes:
measure: Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase
timeFrame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Secondary outcomes:
measure: Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase
timeFrame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
measure: Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment
timeFrame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
measure: Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment
timeFrame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
measure: Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment
timeFrame: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
measure: Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment
timeFrame: Baseline (Day 0) and End of Open-Label Treatment (Week 4)
measure: Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment
timeFrame: Baseline and End of Double-Blind (Week 2)
measure: Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment
timeFrame: Baseline (Day 0) and End of Open-Label (Week 4)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Del Mar Center for Neurorestoration
state: California
Study officials:
affiliation: 8583607260
name: Alex Tahgva, MD
role: PRINCIPAL_INVESTIGATOR
References: