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Effect of tDCS Timing on Safety Memory in PTSD

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ClinicalTrials.gov Identifier: NCT04152772
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Mascha Frank, Brown University

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

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

Detailed Description:
This is a three-arm study composed of five visits over a 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 MRI scans, one done on study day 2 and one done on study day 5.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of tDCS Timing on Safety Memory in PTSD
Estimated Study Start Date : October 31, 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

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.




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


Secondary Outcome Measures :
  1. Neural activity [ Time Frame: MRI scans will occur twice; on day 2 and day 5 of study protocol. ]
    Neural activity will be measured via MRI scans.



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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.

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
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Contact: Mascha van 't Wout-Frank, PhD 401-680-4199 mascha_vant_wout@brown.edu
Contact: Julia Cole, BA 401-680-4199 jcole@butler.org

Locations
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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: Julia Cole, BA    401-680-4199 ext 24199    jcole@butler.org   
Sponsors and Collaborators
Butler Hospital
National Institute of General Medical Sciences (NIGMS)

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Responsible Party: Mascha Frank, Assistant Professor [Research], Brown University
ClinicalTrials.gov Identifier: NCT04152772     History of Changes
Other Study ID Numbers: 1346426-5
P20GM130452 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders