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Completed

NCT Number: NCT04152772

Effect of tDCS Timing on Safety Memory in PTSD

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of PTSD, assessed by the Structured Clinical Interview of DSM-5 (SCID);
  • aged 18-70;
  • ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
  • Stable psychiatric medication use or treatment for at least 6 weeks.

Exclusion criteria

  • Lifetime history of psychotic or bipolar disorder;
  • Current moderate or severe substance use disorder; if mild, not under the influence at time of study participation;
  • Acute suicidal or homicidal ideation as detected on screening instruments or in the investigator team's opinion, is likely to attempt suicide within 6 months;
  • current (or past) significant neurological disorder, injury, or other intracranial pathology including severe traumatic brain injury or lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm;
  • lifetime history of moderate or, current unstable medical conditions;
  • Any problems that would interfere with study participation, including MRI- or tDCS-related contraindications (e.g., implanted metallic devices/substances, metallic tattoos, pregnancy, claustrophobia, holes in the skull, skin abnormalities under stimulation sites), or indication of colorblindness, or presence of any other condition or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or inability to schedule visit days within the allotted time, and/or to have a confounding effect on outcome assessments.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.

Primary outcomes

  1. Skin Conductance Responses

    Time frame: Study visit day 4: during administration of fear extinction memory.

    Main protocol: Threat reactivity as quantified by skin conductance responses to a conditioned and subsequently extinguished stimulus versus a never conditioned stimulus.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2019
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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