Effect of tDCS Timing on Safety Memory in PTSD

NCT ID: NCT04152772

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-22
• Study Completion Date: 2024-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS during extinction learning followed by sham tDCS during consolidation

Active tDCS will be applied during the extinction learning phase followed by sham tDCS during the consolidation phase.

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

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

Sham tDCS during extinction learning followed by active tDCS during consolidation

Sham tDCS will be applied during the extinction learning phase followed by active tDCS during the consolidation phase.

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

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

Sham tDCS during extinction learning followed by sham tDCS during consolidation

Sham tDCS will be applied during the extinction learning phase followed by sham tDCS during the consolidation phase.

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

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

Interventions

transcranial direct current stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Primary diagnosis of PTSD, assessed by the Structured Clinical Interview of DSM-5 (SCID);

2. aged 18-70;

3. ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;

4. Stable psychiatric medication use or treatment for at least 6 weeks.

Exclusion Criteria

1. Lifetime history of psychotic or bipolar disorder;

2. Current moderate or severe substance use disorder; if mild, not under the influence at time of study participation;

3. 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;

4. 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;

5. lifetime history of moderate or, current unstable medical conditions;

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mascha Frank

Associate Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Greenberg, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

References

Faucher CR, Doherty RA, Philip NS, Harle ASM, Cole JJE, Van't Wout-Frank M. Is there a neuroscience-based, mechanistic rationale for transcranial direct current stimulation as an adjunct treatment for posttraumatic stress disorder? Behav Neurosci. 2021 Dec;135(6):702-713. doi: 10.1037/bne0000487. Epub 2021 Aug 2.

Reference Type: BACKGROUND

PMID: 34338547 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P20GM130452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1346426-5

Identifier Type: -

Identifier Source: org_study_id