Effect of tDCS Timing on Safety Memory in PTSD

NCT04152772 | Completed Results DMC

• 2 other identifiers: 1346426-5P20GM130452
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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. 1.One group receiving active stimulation during extinction followed by sham stimulation during consolidation
2. 2.One group receiving sham stimulation during extinction followed by active stimulation during consolidation
3. 3.One group receiving sham stimulation both during extinction and consolidation

Conditions

PTSD

Keywords

safety memory; PTSD; tDCS; ventromedial prefrontal cortex; fear conditioning; context processing

Outcome Measures

Primary Outcomes (1)

• Skin Conductance Responses

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

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

Study Arms (3)

Active tDCS during extinction learning followed by sham tDCS during consolidation

ACTIVE COMPARATOR

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

Device: transcranial direct current stimulation

Sham tDCS during extinction learning followed by active tDCS during consolidation

ACTIVE COMPARATOR

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

Device: transcranial direct current stimulation

Sham tDCS during extinction learning followed by sham tDCS during consolidation

SHAM COMPARATOR

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

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

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

Active tDCS during extinction learning followed by sham tDCS during consolidation; Sham tDCS during extinction learning followed by active tDCS during consolidation; Sham tDCS during extinction learning followed by sham tDCS during consolidation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• 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.

  PMID: 34338547 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Enrollment disruptions due to COVID-19 pandemic resulted in a smaller size than planned (86%; n=62 across three groups out of n=72 planned) for primary outcome analysis and inadequate numbers (51%; n=37 across three groups out of n=72) for analyses of secondary MRI outcomes.

Results Point of Contact

• Title: Mascha van 't Wout-Frank
• Organization: Butler Hospital

Mascha_vant_Wout@brown.edu

401-680-4198

Study Officials

• Benjamin Greenberg, PhD, MD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Model Details: Individuals deemed eligible for the study will be randomized to 1) receiving active tDCS during extinction learning; sham during extinction consolidation, 2) receiving sham during extinction learning; active tDCS during extinction consolidation, 3) receiving sham during extinction learning; sham during extinction consolidation. (Anticipated enrollment: 90 participants).

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: November 22, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)