TDCS-Augmented Prolonged Exposure Therapy

NCT04327362 | Withdrawn FDA Device

• 1 other identifier: 00093774
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tDCS, on the benefits of Prolonged Exposure therapy, or PE, which is an effective treatment for posttraumatic stress disorder, or PTSD. tDCS has been demonstrated to be safe and effective for influencing brain activity by passing a weak electrical current through the scalp. In this study, tDCS is provided in addition to PE treatment, through the National Crime Victim's Research and Treatment Center at MUSC, or the PTSD Clinical Team Clinic within the Ralph H. Johnson VA Medical Center.

Conditions

Posttraumatic Stress Disorder; PTSD; Anxiety; Depression

Keywords

Non-invasive brain stimulation; Transcranial direct current stimulation; Exposure therapy; Prolonged Exposure; Civilians; Veterans; Trauma; Posttraumatic stress disorder; PTSD

Outcome Measures

Primary Outcomes (5)

• Change in Clinician-Rated PTSD Symptom Severity

  Clinician-administered PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

  Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)

• Change in Self-Reported PTSD Symptom Severity

  Self-report scores on the PTSD Symptom Checklist for DSM-5 (PCL-5) Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

  Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)

• Change in Self-Reported Post-traumatic Cognitions

  Self-report scores on the Post-traumatic Cognitions Inventory (PTCI-9) Total scores range from 9 to 63, with high scores indicating greater endorsement of common and problematic trauma-related beliefs.

  Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)

• Change in Depression Symptoms

  Self-report scores on the Beck Depression Inventory, 2nd Edition (BDI-II) Total scores range from 0 to 63, with higher scores indicating greater severity of depression symptoms.

  Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)

• Change in Anxiety Symptoms

  Self-report scores on the Beck Anxiety Inventory (BAI) Total scores range from 0 to 63, with higher scores indicating greater severity of anxiety symptoms.

  Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)

Secondary Outcomes (4)

• Within- and Between-Session Change in Trauma-Related Emotional Distress

  During weekly therapy sessions 1-10, for 10 weeks from baseline.

• Within- and Between-Session Change in Heart Rate

  During weekly therapy sessions 1-10, for 10 weeks from baseline.

• Within- and Between-Session Change in Physiological Activation

  During weekly therapy sessions 1-10, for 10 weeks from baseline.

• Between-Session Change in Trauma Memory Engagement and Emotional Processing

  During weekly therapy sessions 1-10, for 10 weeks from baseline.

Study Arms (5)

Cluster 1: Sham to active tDCS crossover at PE Session 4.

EXPERIMENTAL

Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-3, and 20 min. of active tDCS prior to PE sessions 4-10.

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy

Cluster 2: Sham to active tDCS crossover at PE Session 5.

ACTIVE COMPARATOR

Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-4, and 20 min. of active tDCS prior to PE sessions 5-10.

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy

Cluster 3: Sham to active tDCS crossover at PE Session 6

ACTIVE COMPARATOR

Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-5, and 20 min. of active tDCS prior to PE sessions 6-10.

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy

Cluster 4: Sham to active tDCS crossover at PE Session 7.

ACTIVE COMPARATOR

Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-6, and 20 min. of active tDCS prior to PE sessions 7-10.

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy

Cluster 5: Sham to active tDCS crossover at PE Session 8.

ACTIVE COMPARATOR

Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-7, and 20 min. of active tDCS prior to PE sessions 8-10.

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

Also known as: Soterix Medical 1 x 1 Transcranial Electrical Stimulator (tES)

Cluster 1: Sham to active tDCS crossover at PE Session 4.; Cluster 2: Sham to active tDCS crossover at PE Session 5.; Cluster 3: Sham to active tDCS crossover at PE Session 6; Cluster 4: Sham to active tDCS crossover at PE Session 7.; Cluster 5: Sham to active tDCS crossover at PE Session 8.

Prolonged Exposure Therapy BEHAVIORAL

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Also known as: PE, CBT, Trauma-focused therapy

Cluster 1: Sham to active tDCS crossover at PE Session 4.; Cluster 2: Sham to active tDCS crossover at PE Session 5.; Cluster 3: Sham to active tDCS crossover at PE Session 6; Cluster 4: Sham to active tDCS crossover at PE Session 7.; Cluster 5: Sham to active tDCS crossover at PE Session 8.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65.
• Fluent in English.
• Diagnosis of chronic PTSD based on MINI for DSM-5 (\> 3 mo. post-trauma)
• For Veterans recruited at the Ralph H. Johnson VA only: eligible to receive PE in the PCT clinic.

You may not qualify if:

• Currently receiving psychotherapy for another anxiety- or stress-related condition.
• Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
• Medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems).
• Pregnancy
• Current severe major depressive disorder
• Current, or history of bipolar disorder
• Current, or history of psychotic symptoms
• Serious suicidal risk
• Active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion
• Contraindications for tDCS:
• Metal in the head.
• Implanted brain medical devices.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

National Crime Victim's Research & Treatment Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression; Wounds and Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Adam R. Cobb, Ph.D.

  Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

  PRINCIPAL INVESTIGATOR

• Lisa M. McTeague, Ph.D.

  Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

  PRINCIPAL INVESTIGATOR

• Bethany C. Wangelin, Ph.D.

  Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Customized software involving use of a coding scheme will be used to allow complete blinding to whether active or sham tDCS is administered. The participants, tDCS administrators, therapists, and outcome assessors will remain blind to tDCS condition. The integrity of blinding procedures will be evaluated by self-report questionnaires administered at each treatment visit.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned following stratification by baseline severity of PTSD symptoms, medication status, and sex to one of five clusters defined by the point of cross-over from sham to active tDCS administered just prior to PE therapy sessions, with the earliest cross-over occurring at session 4, and the latest at session 8.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 31, 2020
• Study Start: October 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)