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N/A N=23 Randomized Quadruple-blind Treatment

Synchronized Transcranial Magnetic Stimulation for PTSD

PTSD · Depression

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: PCL-5 Total Score Change — 50.1; 49.2 Units on a scale (PCL-5)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
NEST-1 (Device); SHAM (Device); NEST-2 (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Providence VA Medical Center
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
PCL-5 Total Score Change
50.1; 49.2

Summary

The investigators propose a small, two-site, sham-controlled pilot study of synchronized Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and mood symptoms.

Eligibility Criteria

Inclusion Criteria

  • Must be a Veteran;
  • MRI safe;
  • Meet Diagnostic and Statistical Manual, Fifth Edition (DSM 5) criterion for PTSD (acute or chronic, confirmed by the Clinician Administered PTSD Scale (CAPS) and at least moderate severity defined by a PCL-5 score > 33); AND at least moderate depressive symptom severity (defined by QIDS-SR score > or equal to 11) at baseline visit. Individuals with bipolar II or otherwise unspecified who are currently in a depressed episode are eligible;
  • Baseline score of "moderately ill" or worse on the Clinical Global Impressions-Severity (CGI-S);
  • Stable psychotropic regimen for at least 6 weeks prior to baseline and willing to maintain current dose and regimen throughout study, or no psychotropic medication at all;
  • If female and of child bearing potential, must agree to use an acceptable method of birth control for the duration of the study treatment period;
  • Be willing and able to comply with all study related procedures and visits;
  • Be capable of independently reading and understanding all patient information materials and giving written informed consent.

Exclusion Criteria

  • Pregnant or lactating, or planning on becoming pregnant within the next 3 months;
  • Lifetime history of loss of consciousness (>10 minutes) due to head injury, or lifetime history of head injury with documented evidence of brain injury;
  • Current (or past) significant neurological disorders (seizure disorder, primary or secondary central nervous system (CNS) tumors, stroke, cerebral aneurysm);
  • Unstable medical illness, or significant absence of appropriate medical care;
  • Current axis I primary psychotic disorder or Bipolar I disorder;
  • Active (within the last month) moderate or severe substance (excluding nicotine/caffeine) abuse disorders. Individuals on stable (>3 months), monitored opiate agonist therapy may be included at investigator's discretion;
  • Past failed treatment with rTMS or electroconvulsive therapy (ECT); any past treatment with deep brain stimulation or vagus nerve stimulation;
  • Have an active suicidal intent or plan, or in the opinion of the investigator, is likely to attempt suicide in the next 6 months;
  • Presence of condition or circumstance with potential to prevent study completion;
  • Inability to obtain sufficient EEG to calibrate study device.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02981381). 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.

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