PTSDNCT04152772

Effect of tDCS Timing on Safety Memory in PTSD

A study testing transcranial direct current stimulation in people with PTSD, run by Butler Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: PTSD
What is being tested?: transcranial direct current stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 22 Nov 2019to 31 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Butler Hospital
Providence, Rhode Island, 02906

Other trials in United States

About this study

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:

One group receiving active stimulation during extinction followed by sham stimulation during consolidation
One group receiving sham stimulation during extinction followed by active stimulation during consolidation
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.

Read the 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
Being tested: transcranial direct current stimulation
Keywords: safety memory, PTSD, tDCS, ventromedial prefrontal cortex, fear conditioning, context processing
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04152772
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Device: transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 201931 Jan 2024

First posted5 Nov 2019
Study start22 Nov 2019
Primary completion31 Jan 2024
Study completion31 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PTSDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04152772
Sponsor's protocol ID: 1346426-5
Other IDs: P20GM130452
Status last verified: Oct 2025
First submitted: 31 Oct 2019
Last updated: 21 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34338547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of tDCS Timing on Safety Memory in PTSD
ClinicalTrials.gov ID: NCT04152772
Acronym / sponsor ID: 1346426-5
Conditions: PTSD
Keywords: safety memory, PTSD, tDCS, ventromedial prefrontal cortex, fear conditioning, context processing
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Butler HospitalUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 22 Nov 2019 (actual)
Primary completion: 31 Jan 2024 (actual)
Study completion: 31 Jan 2024 (actual)
First posted: 5 Nov 2019 (actual)
Results: Posted 21 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

One group receiving active stimulation during extinction followed by sham stimulation during consolidation
One group receiving sham stimulation during extinction followed by active stimulation during consolidation
One group receiving sham stimulation both during extinction and consolidation

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
Model description: 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).

Arm	Type	Receives
Active tDCS during extinction learning followed by sham tDCS during consolidation	Active comparator	Device: transcranial direct current stimulationActive tDCS will be applied during the extinction learning phase followed by sham tDCS during the consolidation phase.
Sham tDCS during extinction learning followed by active tDCS during consolidation	Active comparator	Device: transcranial direct current stimulationSham tDCS will be applied during the extinction learning phase followed by active tDCS during the consolidation phase.
Sham tDCS during extinction learning followed by sham tDCS during consolidation	Sham comparator	Device: transcranial direct current stimulationSham tDCS will be applied during the extinction learning phase followed by sham tDCS during the consolidation phase.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
transcranial direct current stimulationActive tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.	Device	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

Primary outcome

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.

Results and safety

Results posted to the registry on 21 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Then Sham Transcranial Direct Current Stimulation	19	19
Sham Then Active Transcranial Direct Current Stimulation	20	20
Sham Then Sham Transcranial Direct Current Stimulation	23	22

Primary outcome: Skin Conductance Responses

Time frame: Study visit day 4: during administration of fear extinction memory.. Mean (Standard Error). Unit: Skin conductance in microsiemens

Measure	Active tDCS During Extinction Learning Followed by Sham tDCS During Consolidation n = 19	Sham tDCS During Extinction Followed by Active tDCS During Consolidation n = 19	Sham tDCS During Extinction Followed by Sham tDCS During Consolidation n = 21
Value	0.075 (0.025)	0.088 (0.026)	0.057 (0.025)

Active tDCS During Extinction Learning Followed by Sham tDCS During Consolidation vs Sham tDCS During Extinction Followed by Active tDCS During Consolidation vs Sham tDCS During Extinction Followed by Sham tDCS During Consolidation: p = 0.02, Mixed Models Analysis

Adverse events

Time frame: One day, following active tDCS or sham stimulation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Active tDCS During Extinction Learning and Sham tDCS During Consolidation	0 of 19 (0%)	16 of 19 (84.2%)	0 of 19
Group 2: Sham tDCS During Extinction Learning and Active tDCS During Consolidation	0 of 20 (0%)	18 of 20 (90%)	0 of 20
Group 3: Sham tDCS During Extinction Learning and Sham tDCS During Consolidation	0 of 23 (0%)	19 of 23 (82.6%)	0 of 23

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34338547Faucher 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.
Individual participant dataSharing planned: No

Related trials for PTSD

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NightWare and Cardiovascular Health in Women With PTSD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin Greenberg, PhD, MD principal investigator

Butler Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation in people with PTSD, run by Butler Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Conductance Responses (time frame: Study visit day 4: during administration of fear extinction memory.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.