N/A
Completed N=6
Cranial Electrotherapy Stimulation (CES) Therapy
Source: ClinicalTrials.gov NCT02453347 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms — 44.25 scores on a scale
Summary
The primary aim of this proposed study is to gather preliminary data for CES use in treating PTSD and anxiety symptoms in OEF/OIF Veterans with PTSD and a history of TBI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms |
44.25 | — |
| PRIMARY State-Trait Anxiety Inventory (STAI) |
81.375 | — |
| PRIMARY Beck Depression Inventory (BDI) |
25 | — |
| PRIMARY TFI (Tinnitus Functional Index) |
94.875 | — |
| PRIMARY MPAI (Mayo Portland Adaptability Inventory) |
48 | — |
| PRIMARY WAIS (Wechsler Adult Intelligence Scale) Symbol Search |
26.75 | — |
| PRIMARY WAIS Coding - Wechsler Adult Intelligence Scale |
55.5 | — |
| SECONDARY Dizziness- NSI (Neurobehavioral Symptom Inventory) |
40.8 | — |
| SECONDARY Headache - HIT6 (Headache Impact Test) |
62.37 | — |
| SECONDARY Sleep - Pittsburgh Sleep Quality Index (PSQI) |
10.5 | — |
Eligibility Criteria
Inclusion Criteria
- Male outpatient, OEF/OIF/OND Veterans diagnosed during the course of clinical care with mild TBI and PTSD, and screened positive for anxiety
- Good medical health and stable chronic medical conditions.
- No current alcohol or substance abuse.
Exclusion Criteria
- Patients with moderate or severe TBI or seizure disorders.
- Prior CES use
- Diagnosis of Bipolar Disorder, Schizophrenia, or other psychiatric condition that would require inpatient hospitalization or medical disease that would impair reliable participation in the trial.
Data sourced from ClinicalTrials.gov (NCT02453347). 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.