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Tests treatment safety and results for PTSD - Post Traumatic Stress Disorder
Official title Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians
ClinicalTrials.gov ID: NCT06806267
What this study is testing
- What it's testing
- A new method is being tested to assist individuals in Ukraine with Post-Traumatic Stress Disorder (PTSD), including veterans and civilians affected by war. The study is a collaboration among Ukrainian healthcare institutions and the Charité Berlin.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- The participant's index trauma event must have occurred when the participant was ≥13 years of age.
- In the opinion of the Investigator the participant has a high probability for adherence with and completion of the study.
- The participant has the ability to comply with study procedures.
You likely can't join if
- Individuals with Epilepsy, Seizures or Severe Brain Injuries
- Individuals with Implanted Electronic Devices (Pacemakers, Cochlear Implants, etc.)
- Individuals with Scalp or Skin Issues at electrode placement sites
- Pregnant Individuals
- Individuals with tinnitus Medical Conditions
- It has been less than 6 months since the participant's index trauma event occurred, at the time of the Screening Visit.
See the full eligibility criteria
Who can join
- 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...
- 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...
- The participant's index trauma event must have occurred when the participant was ≥13 years of age.
- In the opinion of the Investigator the participant has a high probability for adherence with and completion of the study.
- The participant has the ability to comply with study procedures.
- The participant is fluent in Ukrainian and able to understand and comply with written and verbal protocol-related requirements.
- The participant has received study inclusion approval through an adjudication process as to final suitability for the study.
What rules you out
- Individuals with Epilepsy, Seizures or Severe Brain Injuries
- Individuals with Implanted Electronic Devices (Pacemakers, Cochlear Implants, etc.)
- Individuals with Scalp or Skin Issues at electrode placement sites
- Pregnant Individuals
- Individuals with tinnitus Medical Conditions
- It has been less than 6 months since the participant's index trauma event occurred, at the time of the Screening Visit.
- The participant has current and ongoing exposure to the trauma that caused their PTSD.
- 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...
- The participant has severe depression as measured by a score of ≥35 on the Montgomery-Åsberg Depression Rating Scale (MADRS) at the Screening Visit.
- 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...
- The participant has a history of moderate to severe traumatic brain injury.
- The participant has a history of seizure disorders, uncontrolled sleep apnea or severe neurologic disease.
- The participant has any moderate or severe substance use disorder according to DSM-5 in the 12 months prior to the Screening Visit.
- The participant has a score of \>15 points on the Alcohol Use Disorders Identification Test (AUDIT) at the Screening Visit.
- 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.
- 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.
- The participant has negative experience or reaction to VR technology.
- The participant has significant cognitive impairments affecting instruction comprehension.
- The participant has any clinically significant ECG abnormality as determined by the Investigator at the Screening Visit.
- The participant has pronounced adverse physiological reactions to VR that remain unmanageable
- 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
- The participant is receiving concurrent trauma-based psychotherapy such as Cognitive Behaviour Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy.
- 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...
- The participant is a member of the Ukrainian military currently serving on active duty.
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.