| Eligibility |
Inclusion Criteria:
1. To ensure participants can safely receive Alpha-Stim®, eligible participants must meet
all established screening criteria for safety during Alpha-Stim® using a safety
screener (as assessed during phone screen and medical records review). We are
screening to access for metal. These are conservative measures require a patient not
having the following (unless MRI-safe): Cardiac pacemaker, implanted device (deep
brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic
spinal cord. The patient would additionally be required to not have an implanted
cardiac defibrillator;
2. Outpatients 18-70 years of age (inclusive);
3. Meet DSM-V criteria for PTSD (acute or chronic) at the time of the screening and/or
baseline visit; symptoms.
4. Have a baseline score of "Moderately Ill" or worse on the CGI-S;
5. Be on a stable psychotropic regimen for at least 6 weeks prior to baseline, or no
psychotropic medication at all (for at least 6 weeks prior to baseline), and be
willing to maintain the current regimen and dosing for the duration of the study
(unless medically necessary to make changes with notification of research staff);
(7) If female and of child bearing potential, agree to use an acceptable method of birth
control for the duration of the study treatment period; (8) Be willing and able to comply
with all study related procedures and visits; (9) Be capable of independently reading and
understanding patient information materials and giving written informed consent.
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Exclusion Criteria:
Participants will be excluded from participation if they meet any of the following:
1. Are pregnant or lactating or planning to become pregnant within the next three months;
2. Have a lifetime history of loss of consciousness due to head injury for greater than
10 minutes, or any lifetime history of loss of consciousness due to a head injury with
documented evidence of brain injury (including brain atrophy);
3. Current (or past if appropriate) significant neurological disorder, or lifetime
history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d)
cerebral aneurysm;
4. Unstable medical illness, or, in the opinion of the investigator, significant absence
of appropriate medical care;
5. Current Axis 1 primary psychotic disorder, or bipolar I disorder, active
moderate/severe substance use disorders (within the last month as assessed by review
of the medical records and veteran self-report, excluding nicotine/caffeine). Veterans
on stable (>3 months), monitored opiate agonist therapy may be included at the
investigator's discretion;
6. Past failed treatment with rTMS or ECT; any past treatment with deep brain stimulation
or vagus nerve stimulation;
7. Have active suicidal intent or plan as detected on screening assessments, or in the
Investigator's opinion, is likely to attempt suicide within the next six months;
8. Mental retardation or cognitive impairment
9. History of stroke, Parkinson's Disease, Multiple Sclerosis, or seizures
10. Current use of Transcutaneous electrical nerve stimulation (TENS) unit
11. Previous history of Alpha-Stim® use
12. Inability to read and write in English
13. Incapacity to make informed medical decisions for any reason
14. Pregnancy: Pregnant women are not eligible for the study. Women with potential for
pregnancy will receive a pregnancy test provided by the VA prior to the study. Women
of childbearing capacity are eligible for the study. Contraceptive plans will be
discussed and if they are determined to be inadequate, the participant will be
excluded from the study.
15. Presence of an implanted defibrillator or pacemaker device.
16. Demonstrate the presence of any other condition or circumstance that, in the opinion
of the investigator, has the potential to prevent study completion and/or to have a
confounding effect on outcome assessments.
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