Effect of tDCS Timing on Safety Memory in PTSD

PTSD Clinical Trial

Official title:

Effect of tDCS Timing on Safety Memory in PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152772
• Other study ID #: 1346426-5
• Secondary ID: P20GM130452
• Status: Completed
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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+

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychophysiological reactivity	Change in fear response as indicated by skin conductance response	During fear conditioning (day 3), fear extinction (day 4) and fear extinction recall (day 5) of study protocol.
Primary	SUB-STUDY: accuracy in contextual processing	Assessed by experimental tasks that assess configural and elemental contextual learning and memory.	All sub-study experimental procedures will occur online and in one 'visit' and take approximately 60-90 minutes to complete.
Secondary	Neural activity	Neural activity will be measured via MRI scans.	MRI scans will collected on day 2 of study protocol.