Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06806267
Eligibility Criteria:
Inclusion Criteria:
* Participants are eligible to be included in the study only if all of the following criteria apply:
Age · The participant is 18 to 75 years of age, inclusive, at the time the informed consent form (ICF) is signed.
Type of Participant and Disease Characteristics:
* The participant has a current diagnosis of PTSD as defined by the CAPS-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at the Screening Visit and Baseline Visit and no \>25% change in score from Screening to Baseline.
* The participant's index trauma event must have occurred when the participant was ≥13 years of age.
1. In the opinion of the Investigator the participant has a high probability for adherence with and completion of the study.
2. The participant has the ability to comply with study procedures.
3. The participant is fluent in Ukrainian and able to understand and comply with written and verbal protocol-related requirements.
4. The participant has received study inclusion approval through an adjudication process as to final suitability for the study.
Exclusion Criteria:
1. Individuals with Epilepsy, Seizures or Severe Brain Injuries
2. Individuals with Implanted Electronic Devices (Pacemakers, Cochlear Implants, etc.)
3. Individuals with Scalp or Skin Issues at electrode placement sites
4. Pregnant Individuals
5. Individuals with tinnitus
Medical Conditions
1. It has been less than 6 months since the participant's index trauma event occurred, at the time of the Screening Visit.
2. The participant has current and ongoing exposure to the trauma that caused their PTSD.
3. The participant has complex PTSD, defined as a condition that may develop following exposure to an event or series of events of an extreme and prolonged or repetitive nature, which the participant experienced as extremely threatening or horrific and from which escape was difficult or impossible (e.g., torture, slavery, genocide campaigns, prolonged domestic violence, repeated childhood sexual or physical abuse). If affect dysregulation and interpersonal dysfunction are primary over other core PTSD symptoms, in the Investigator's opinion, participants should be excluded.
4. The participant has severe depression as measured by a score of ≥35 on the Montgomery-Åsberg Depression Rating Scale (MADRS) at the Screening Visit.
5. The participant has bipolar disorder, borderline personality disorder and other psychotic disorders as identified at the Screening Visit using the Structured Clinical Interview for DSM-5 Disorders - Clinical Trials Version (SCID-5-CT) and Personality Disorders (SCID-5-PD).
6. The participant has a history of moderate to severe traumatic brain injury.
7. The participant has a history of seizure disorders, uncontrolled sleep apnea or severe neurologic disease.
8. The participant has any moderate or severe substance use disorder according to DSM-5 in the 12 months prior to the Screening Visit.
9. The participant has a score of \>15 points on the Alcohol Use Disorders Identification Test (AUDIT) at the Screening Visit.
10. The participant is at an increased risk of suicide, defined as:
* Any suicide attempt in the 12 months prior to the Screening Visit disclosed by the participant using the Columbia Suicide Severity Rating Scale (C-SSRS)
* Any suicidal ideation with intent (yes to item 4 and/or 5) in the past 6 months or suicidal behaviour in the past 12 months, as captured at the Screening Visit or Baseline Visit using the C-SSRS
* A score \>4 on item 10 of the MADRS at the Screening Visit.
11. The participant has a systolic blood pressure value \>140 mmHg or diastolic blood pressure value \>90 mmHg at the Screening Visit or Baseline Visit. Two repeat measures are allowed at the discretion of the Investigator.
12. The participant has negative experience or reaction to VR technology.
13. The participant has significant cognitive impairments affecting instruction comprehension.
14. The participant has any clinically significant ECG abnormality as determined by the Investigator at the Screening Visit.
15. The participant has pronounced adverse physiological reactions to VR that remain unmanageable
16. The participant is receiving concurrent trauma-based psychotherapy such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy.
Prior/Concomitant Therapy
1. The participant is receiving concurrent trauma-based psychotherapy such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy.
2. The participant has used marijuana or cannabinoid containing products daily (occasional use is allowed) for recreational use or self-medication (prescribed or otherwise) for the treatment of symptoms of PTSD or any other CNS disorder within 60 days of the Screening Visit.
Prior/Concurrent Clinical Study Experience
1\. The participant is currently enrolled in OR has previously participated in another investigational study in which an investigational medication (e.g., drug, vaccine, invasive device) was administered within 30 days before the ICF for this study is signed.
Other Exclusions
1. The participant is a member of the Ukrainian military currently serving on active duty.
2. The participant is in the process of litigating for compensation for a psychiatric disorder. Participants who are in the process of applying for medical or Veterans Affairs benefits and/or those who have settled a disability claim prior to enrolment in the trial are eligible.
3. The participant is not suitable to participate in the study, in the opinion of the investigator, because of clinically significant findings on medical history that could interfere with the objectives of the study or put the participant at risk or for any other reason the investigator deems applicable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06806267
Study Brief:
Protocol Section:
NCT06806267