We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of tDCS Timing on Safety Memory in PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04152772
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Mascha Frank, Brown University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The primary purpose of this study is to investigate the effects of tDCS timing on safety 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 and sham during consolidation
  2. One group receiving sham stimulation during extinction and active during consolidation
  3. One group receiving sham stimulation both during extinction and consolidation

This study will also include an online sub-study focused on contextual processing along the PTSD spectrum. A maximum of 500 participants will be recruited using an online, panel-based platform.


Condition or disease Intervention/treatment Phase
PTSD Device: transcranial direct current stimulation Not Applicable

Detailed Description:

This is a three-arm study composed of four to five visits over an approximate period of three weeks. Ninety participants will be exposed to a fear conditioning, extinction and recall paradigm at three separate study visits; one of these study visits will include active or sham transcranial direct current stimulation (tDCS) for a period of 15-20 minutes. Additional study procedures will include a screening period and two optional MRI scans, one done on study day 2 and one done on study day 5.

SUB-STUDY: The objective of this sub-study is to test performance differences between configural and elemental 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 configural and elemental contextual learning and memory. They will also provide demographic information and complete questionnaires.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)

SUB-STUDY: Individuals deemed eligible will all complete the same experimental tasks and questionnaires. (Anticipated enrollment: 500 participants)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of tDCS Timing on Safety Memory in PTSD
Actual Study Start Date : November 22, 2019
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Active during extinction learning / Sham during consolidation
Active tDCS stimulation will be applied during the extinction learning phase. Sham tDCS stimulation will be applied during the consolidation phase.
 Device: transcranial direct current stimulation
Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.
Active Comparator: Sham during extinction learning / Active during consolidation
Sham tDCS stimulation will be applied during the extinction learning phase. Active tDCS stimulation will be applied during the consolidation phase
 Device: transcranial direct current stimulation
Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.
Sham Comparator: Sham during extinction learning / Sham during consolidation
Sham tDCS stimulation will be applied during both the extinction learning phase and the consolidation phase.
 Device: transcranial direct current stimulation
Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Psychophysiological reactivity [ Time Frame: During fear conditioning (day 3), fear extinction (day 4) and fear extinction recall (day 5) of study protocol. ]
    Change in fear response as indicated by skin conductance response

  2. SUB-STUDY: accuracy in contextual processing [ Time Frame: All sub-study experimental procedures will occur online and in one 'visit' and take approximately 60-90 minutes to complete. ]
    Assessed by experimental tasks that assess configural and elemental contextual learning and memory.


Secondary Outcome Measures :
  1. Neural activity [ Time Frame: MRI scans will collected on day 2 of study protocol. ]
    Neural activity will be measured via MRI scans.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

SUB-STUDY Inclusion criteria: aged 18+

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152772


Contacts
Layout table for location contacts
Contact: Mascha van 't Wout-Frank, PhD 401-680-4199 mascha_vant_wout@brown.edu
Contact: Rosie Luther, BS 401-680-4199 MLuther@butler.org

Locations
Layout table for location information
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Mascha van 't Wout-Frank, PhD    401-680-4199 ext 24199    mascha_vant_wout@brown.edu   
Contact: Rosie Luther, BS    401-680-4199 ext 24199    MLuther@butler.org   
Sponsors and Collaborators
Butler Hospital
National Institute of General Medical Sciences (NIGMS)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Mascha Frank, Assistant Professor [Research], Brown University
ClinicalTrials.gov Identifier: NCT04152772    
Other Study ID Numbers: 1346426-5
P20GM130452 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mascha Frank, Brown University:
safety memory
PTSD
tDCS
 ventromedial prefrontal cortex
fear conditioning
context processing
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders