PTSD Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are between 18 and 75 years old at the time of signing the consent form.
• People who have been diagnosed with PTSD based on a structured clinical assessment, with symptoms that meet a minimum severity level at both the screening and baseline visits, and whose scores remain relatively stable between those two visits.
• People whose traumatic event happened when they were 13 years of age or older.
• People who the study doctor believes are likely to stick with and complete the study.
• People who are able to follow the study procedures and requirements.
• People who are fluent in Ukrainian and can understand and follow both written and spoken instructions related to the study.
• People whose eligibility has been confirmed through an additional approval process run by the study team.

Who may not be able to join:

• People who have epilepsy, seizures, or severe brain injuries.
• People who have an implanted electronic device, such as a pacemaker or cochlear implant.
• People who have scalp or skin problems at the areas where electrodes would be placed.
• People who are pregnant.
• People who have tinnitus (ringing in the ears).
• People whose traumatic event happened less than 6 months before the screening visit.
• People who are still regularly exposed to the situation or event that caused their PTSD.
• People with complex PTSD — a form of PTSD linked to prolonged or repeated trauma such as torture, slavery, genocide, ongoing domestic violence, or repeated childhood abuse — particularly where difficulties managing emotions and relationships are the main concern, in the study doctor's view.
• People with severe depression, as measured by a specific rating scale score at screening.
• People who have been identified as having bipolar disorder, borderline personality disorder, or other psychotic disorders based on structured clinical interviews at the screening visit.
• People with a history of moderate to severe traumatic brain injury.
• People with a history of seizure disorders, uncontrolled sleep apnea, or severe neurological disease.
• People who have had a moderate or severe substance use disorder (as defined by standard clinical criteria) in the 12 months before the screening visit.
• People whose alcohol use scores above a certain level on a standardised alcohol screening tool at the screening visit.
• People considered to be at increased risk of suicide, including those who have made a suicide attempt in the past 12 months, had suicidal thoughts with intent in the past 6 months, shown suicidal behaviour in the past 12 months, or scored above a certain level on a depression scale item related to suicidal thoughts.
• People with a blood pressure reading above 140/90 mmHg at the screening or baseline visit (with up to two repeat measurements allowed at the study doctor's discretion).
• People who have had a negative experience or reaction to virtual reality (VR) technology.
• People with significant cognitive difficulties that affect their ability to understand instructions.
• People with a clinically significant abnormality on a heart tracing (ECG), as determined by the study doctor at screening.
• People who experience strong and unmanageable physical reactions to virtual reality.
• People currently receiving trauma-focused psychological therapies such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, or Eye Movement Desensitisation and Reprocessing Therapy.
• People who have used marijuana or cannabinoid products daily (occasional use may be permitted) in the 60 days before the screening visit, whether for recreational use or to manage PTSD or other mental health symptoms.
• People who are currently enrolled in, or who have participated in, another clinical study involving an investigational treatment within 30 days before signing the consent form for this trial.
• People who are currently serving on active duty in the Ukrainian military.
• People who are in the process of pursuing legal compensation for a psychiatric disorder (note: people applying for medical or Veterans Affairs benefits, or those who have already settled a disability claim before joining, are not excluded).
• People the study doctor considers unsuitable for any other medical or safety reason.

Important: Always verify eligibility with the trial site directly before applying.