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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 26, 2019
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Mascha Frank, Brown University

Tracking Information
First Submitted Date  ICMJE October 31, 2019
First Posted Date  ICMJE November 5, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE November 22, 2019
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04152772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of tDCS Timing on Safety Memory in PTSD
Official Title  ICMJE Effect of tDCS Timing on Safety Memory in PTSD
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE PTSD
Intervention  ICMJE Device: transcranial direct current stimulation
Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.
Study Arms  ICMJE
  • 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.
    Intervention: Device: transcranial direct current stimulation
  • 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
    Intervention: Device: transcranial direct current stimulation
  • 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.
    Intervention: Device: transcranial direct current stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2024
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04152772
Other Study ID Numbers  ICMJE 1346426-5
P20GM130452 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mascha Frank, Brown University
Study Sponsor  ICMJE Butler Hospital
Collaborators  ICMJE National Institute of General Medical Sciences (NIGMS)
Investigators  ICMJE Not Provided
PRS Account Butler Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP