Effect of tDCS Timing on Safety Memory in PTSD

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT04152772
• Lead Sponsor: Butler Hospital

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.

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 Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Study Start: 2019-11-22
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 522

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.

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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+

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active during extinction learning / Sham during consolidation	transcranial direct current stimulation	Active tDCS stimulation will be applied during the extinction learning phase. Sham tDCS stimulation will be applied during the consolidation phase.
Sham during extinction learning / Active during consolidation	transcranial direct current stimulation	Sham tDCS stimulation will be applied during the extinction learning phase. Active tDCS stimulation will be applied during the consolidation phase
Sham during extinction learning / Sham during consolidation	transcranial direct current stimulation	Sham tDCS stimulation will be applied during both the extinction learning phase and the consolidation phase.

Primary Outcome Measures

Name	Time	Method
Psychophysiological reactivity	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
SUB-STUDY: accuracy in contextual processing	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

Name	Time	Method
Neural activity	MRI scans will collected on day 2 of study protocol.	Neural activity will be measured via MRI scans.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States