None listed
Conditions
Brief summary
Post-Traumatic Stress Disorder (PTSD) is a common and disabling condition. It has significant costs in terms of lost productivity, treatment costs, morbidity and excess mortality (including suicide and premature death from co-morbid medical conditions). Current treatments are only effective in one third of patients. There is a pressing need for new treatments. Transcranial Direct Current Stimulation is a novel, non-invasive method of stimulating the brain in order to produce clinical effects. It has been used widely to treat symptoms of depression. Only one small study has examined its effect on symptoms of PTSD, the results were promising. tDCS is an easily administered treatment with low cost and few side-effects. It can be provided using small portable devices and can be administered remotely. This can address one of the key obstacles to current neurostimulation treatments, that of access. The proposed study aims to investigate the impact of tDCS compared to sham tDCS in participants with severe PTSD. Participants will be recruited from the Psychological Trauma Recovery Service inpatient unit. After giving informed consent, participants will be randomised to receive either active or sham tDCS for 20 minutes/day for 10 days over 2 weeks. Measured outcomes will include symptoms of PTSD, depression, side-effects of tDCS and results of electroencephalogram (EEG) studies. Should this study replicate the successful findings of a similar recently published trial then this treatment could be a very significant addition to the currently available treatments for PTSD.
Interventions
Administration of transcranial Direct Current Stimulation using a Soterix Mini-CT Low-Intensity Transcranial Electrical Stimulator with bifrontal electrode montage. Anode located over the left dorsolateral prefrontal cortex and cathode over the right dorsolateral prefrontal cortex (corresponding to F3 and F4 respectively). A direct current of 2.0 milliamps delivered for 20 minutes. Electrodes located and applied for each treatment by a medically trained administrator. Treatment continuously supe
Administration of transcranial Direct Current Stimulation using a Soterix Mini-CT Low-Intensity Transcranial Electrical Stimulator with bifrontal electrode montage. Anode located over the left dorsolateral prefrontal cortex and cathode over the right dorsolateral prefrontal cortex (corresponding to F3 and F4 respectively). A direct current of 2.0 milliamps delivered for 20 minutes. Electrodes located and applied for each treatment by a medically trained administrator. Treatment continuously supervised. Treatment administered once/day for 10 consecutive days (Monday to Friday). At the completion of treatment the device records a log that shows the number of PAUSE EVENTS (number of times device PAUSED), CRITICAL EVENTS (number of times device detected POOR contact quality or outside the desired range), CRITICAL TIME (duration device was operated under POOR quality conditions), and TOTAL TIME (total duration of the session run).
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Admitted to hospital • Clinical diagnosis of PTSD by Consultant Psychiatrist • Capacity for consent • PCL-5 score above 50
Exclusion criteria
• Presence of metallic objects in or around the head • Medical disorder such as epilepsy or head injury • High suicide risk (measured by standard Risk Assessment, requiring hourly or greater observation)
Outcome results
None listed