Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians

Recruiting now · Not applicable

Conditions studied: PTSD - Post Traumatic Stress Disorder

In brief

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. What is PTSD? PTSD can occur after a distressing or traumatic experience, such as exposure to war. It can result in persistent negative memories, nightmares, heightened nervousness, or avoidance of reminders associated with the event. Purpose of the Study Two innovative treatments for PTSD are being tested: 1. Virtual Reality Therapy: This approach uses specialized goggles to create a safe and realistic virtual environment where individuals can confront memories and process emotions with guidance from a therapist. 2. Brain Stimulation Therapy (tDCS): This method applies a gentle electrical current to the scalp to support improved emotional regulation by the brain. The study aims to determine whether combining these two treatments is more effective than using virtual reality therapy alone. Participant Involvement Participants will: * Attend 10 therapy sessions over several weeks. * Use virtual reality goggles to engage with safe scenarios related to their memories, guided by a therapist. * Potentially receive brain stimulation therapy during some virtual reality sessions. * Learn relaxation techniques to help manage stress and enhance emotional control. Potential Benefits for Participants * These treatments may reduce symptoms such as intrusive memories, anxiety, and depression. * Participants may experience increased calmness, resilience, and improved ability to manage daily life. This study also has the potential to advance PTSD treatment methods for others in the future.

Key facts

Study ID

NCT06806267

Run by

Malek Bajbouj

People needed

514

Starts

2025-04-22

Expected to finish

2027-06-30

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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, 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.
• 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.

You may not qualify 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.
• 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 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.
• 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 Version (SCID-5-CT) and Personality Disorders (SCID-5-PD).
• 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.

Where it is running

• Charité - Universitätsmedizin Berlin — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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