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Effect of tDCS Timing on Safety Memory in PTSD

Primary Purpose

PTSD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for PTSD focused on measuring safety memory, PTSD, tDCS, ventromedial prefrontal cortex, fear conditioning, context processing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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+

Sites / Locations

  • Butler HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Active during extinction learning / Sham during consolidation

Sham during extinction learning / Active during consolidation

Sham during extinction learning / Sham during consolidation

Arm Description

Active tDCS stimulation will be applied during the extinction learning phase. Sham tDCS stimulation will be applied during the consolidation phase.

Sham tDCS stimulation will be applied during the extinction learning phase. Active tDCS stimulation will be applied during the consolidation phase

Sham tDCS stimulation will be applied during both the extinction learning phase and the consolidation phase.

Outcomes

Primary Outcome Measures

Psychophysiological reactivity
Change in fear response as indicated by skin conductance response
SUB-STUDY: accuracy in contextual processing
Assessed by experimental tasks that assess configural and elemental contextual learning and memory.

Secondary Outcome Measures

Neural activity
Neural activity will be measured via MRI scans.

Full Information

First Posted
October 31, 2019
Last Updated
May 31, 2023
Sponsor
Butler Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04152772
Brief Title
Effect of tDCS Timing on Safety Memory in PTSD
Official Title
Effect of tDCS Timing on Safety Memory in PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: One group receiving active stimulation during extinction and sham during consolidation One group receiving sham stimulation during extinction and active during consolidation 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
safety memory, PTSD, tDCS, ventromedial prefrontal cortex, fear conditioning, context processing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active during extinction learning / Sham during consolidation
Arm Type
Active Comparator
Arm Description
Active tDCS stimulation will be applied during the extinction learning phase. Sham tDCS stimulation will be applied during the consolidation phase.
Arm Title
Sham during extinction learning / Active during consolidation
Arm Type
Active Comparator
Arm Description
Sham tDCS stimulation will be applied during the extinction learning phase. Active tDCS stimulation will be applied during the consolidation phase
Arm Title
Sham during extinction learning / Sham during consolidation
Arm Type
Sham Comparator
Arm Description
Sham tDCS stimulation will be applied during both the extinction learning phase and the consolidation phase.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.
Primary Outcome Measure Information:
Title
Psychophysiological reactivity
Description
Change in fear response as indicated by skin conductance response
Time Frame
During fear conditioning (day 3), fear extinction (day 4) and fear extinction recall (day 5) of study protocol.
Title
SUB-STUDY: accuracy in contextual processing
Description
Assessed by experimental tasks that assess configural and elemental contextual learning and memory.
Time Frame
All sub-study experimental procedures will occur online and in one 'visit' and take approximately 60-90 minutes to complete.
Secondary Outcome Measure Information:
Title
Neural activity
Description
Neural activity will be measured via MRI scans.
Time Frame
MRI scans will collected on day 2 of study protocol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. SUB-STUDY Inclusion criteria: aged 18+
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mascha van 't Wout-Frank, PhD
Phone
401-680-4199
Email
mascha_vant_wout@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mascha van 't Wout-Frank, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mascha van 't Wout-Frank, PhD
Phone
401-680-4199
Ext
24199
Email
mascha_vant_wout@brown.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34338547
Citation
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.
Results Reference
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Effect of tDCS Timing on Safety Memory in PTSD

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