Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06806267

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

Led by Malek Bajbouj · Updated on 2026-02-13

514

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

Sponsors

M

Malek Bajbouj

Lead Sponsor

B

Bogomolets National Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years at the time of informed consent.
  • Current PTSD diagnosis confirmed by CAPS-5 with a severity score of 30 or higher and stable between screening and baseline.
  • Traumatic event causing PTSD occurred at age 13 or older.
  • Ability to adhere to and complete the study protocol as judged by the investigator.
  • Ability to understand and comply with study procedures in Ukrainian.
  • Approval for study inclusion after final adjudication process.
Not Eligible

You will not qualify if you...

  • History of epilepsy, seizures, or severe brain injuries.
  • Presence of implanted electronic devices like pacemakers or cochlear implants.
  • Scalp or skin conditions at electrode placement sites.
  • Pregnancy.
  • Presence of tinnitus.
  • Trauma event occurred less than 6 months before screening.
  • Ongoing exposure to the trauma causing PTSD.
  • Diagnosis of complex PTSD with predominant affect dysregulation and interpersonal dysfunction.
  • Severe depression (MADRS score 35 or higher) at screening.
  • Bipolar disorder, borderline personality disorder, or other psychotic disorders.
  • History of moderate to severe traumatic brain injury.
  • History of seizure disorders, uncontrolled sleep apnea, or severe neurological disease.
  • Moderate or severe substance use disorder within 12 months prior to screening.
  • High alcohol use (AUDIT score above 15) at screening.
  • Increased suicide risk based on recent attempts, ideation, or rating scores.
  • High blood pressure above specified thresholds at screening or baseline.
  • Negative reaction or experience with virtual reality technology.
  • Significant cognitive impairments affecting understanding.
  • Clinically significant ECG abnormalities.
  • Unmanageable adverse reactions to virtual reality.
  • Receiving concurrent trauma-based psychotherapy.
  • Daily marijuana or cannabinoid use within 60 days before screening.
  • Participation in other investigational studies with medication within 30 days before consent.
  • Active duty military members.
  • Currently litigating for psychiatric disorder compensation.
  • Any other medical or clinical conditions deemed unsuitable by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Charité - Universitätsmedizin Berlin

Berlin, Germany, 10117

Actively Recruiting

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Research Team

Y

Yuliya Kovalchuk, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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