NCT04152772

Effect of tDCS Timing on Safety Memory in PTSD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to investigate the effects of tDCS timing on extinction memory in PTSD. A total of 90 participants will be randomized equally across one of three groups: 1. One group receiving active stimulation during extinction followed by sham stimulation during consolidation 2. One group receiving sham stimulation during extinction followed by active stimulation during consolidation 3. One group receiving sham stimulation both during extinction and consolidation This study also includes an online sub-study (Aim 2) focused on contextual processing along the PTSD spectrum. The online study tests if there is an association between threat and non-threat learning in contextual and non-contextual situations. A maximum of 500 participants will be recruited using an online, panel-based platform.

Detailed description

This is a three-arm study composed of four to five visits over an approximate period of three weeks. Up to ninety participants are exposed to a fear conditioning, extinction, and extinction memory paradigm at three separate study visits (day 3-5); one of these study visits will include active or sham transcranial direct current stimulation (tDCS) for a period of 15 minutes. Skin conductance reactivity during extinction memory (day 5) is the primary outcome. Additional study procedures include a screening period (day 1) and two optional MRI scans, one done on study day 2 and one done on study day 5. As the completion of MRI scans are an optional study component, MRI-related data is not reported here. SUB-STUDY: The objective of this sub-study is to test performance differences between contextual and non-contextual processing in individuals across the PTSD spectrum using an online, panel-based platform. Following a within-subjects study design, up to 500 adult participants, 18-89 years, will be asked to complete experimental tasks that assess contextual (configural) and non-contextual (elemental) threat and non-threat learning. They will also provide demographic information (age, sex, ethnicity) and complete questionnaires assessing self-reported PTSD, anxiety, and depression severity. As this sub-study does not reflect a randomized clinical trial (no groups, no randomization, no intervention), no further information is reported here.

Conditions

• PTSD

Interventions

Type	Name	Description
DEVICE	transcranial direct current stimulation	Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.

Timeline

• Start date: 2019-11-22
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2019-11-05
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

1 site across 1 country: United States