NCT05419999

Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy

Safety, Feasibility, and Benefits of Transcranial Direct Current Stimulation (tDCS) in Human Subjects With Posttraumatic Stress Disorder (PTSD) Receiving an Exposure-based, Behavioral Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder posttraumatic stress disorder (PTSD).

Detailed description

While the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation in human subjects with PTSD. Towards this end, the study team will conduct a single-blind randomized controlled pilot study of transcranial direct current stimulation (tDCS) vs. a sham condition in a sample of 40 adults with PTSD receiving 5 weekly sessions of Written Exposure Therapy (WET), an exposure-based, behavioral psychotherapy for PTSD.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	Soterix 1x1 tDCS mini CT	During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
OTHER	Sham Soterix 1x1 tDCS Mini CT	Sham setting is used on the Soterix transcranial electrical stimulator
BEHAVIORAL	Written Exposure Therapy (WET)	An exposure-based, behavioral psychotherapy for PTSD.

Timeline

• Start date: 2023-01-09
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2022-06-15
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study