Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress Disorder

September 8, 2013 updated by: Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
The purpose of this study is to test whether transcranial direct current stimulation (tDCS) can enhance the clinical efficacy of trauma-focused therapy for posttraumatic stress disorder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic stress disorder (PTSD) is a debilitating, often-chronic psychiatric condition emerging following a severe traumatic event. Trauma-focused therapy techniques, and primarily Prolonged Exposure, constitute the primary first-line treatment. While effective to some degree, these methods have several substantial shortcomings, including limited patient compliance (long process) and responsiveness, sustained therapeutic effect, and susceptibility to spontaneous symptom relapse. Thus, there is a considerable need for enhancing the efficacy of PTSD treatment.

Dominant theories in the field of PTSD emphasize a key role for threat-related learning and memory processes in the underlying etiology and maintenance of PTSD symptoms, such as absent or insufficient extinction of learned fear associations. Indeed, trauma-focused therapy protocols typically involve repeated imaginal or in vivo recall of traumatic memories in a systematic, controlled manner, while employing anxiety-reducing techniques, and without experiencing additional external trauma. Thus, these therapies parallel cue-extinction training within a model of learning and unlearning of conditioned responses, with the patient's diminished fear response over successive extinction trials reflecting the weakening of trauma-induced associations between the fear-provoking stimuli and the conditioned fear response. Extinction of fear responses is thus generally assumed to be one the most important underlying mechanisms of exposure therapy. Noting the limited efficacy of trauma-focused treatment (and in particular the spontaneous relapse), there is much room for improving the effectiveness of this cue-extinction process in a manner that is not dangerous to the patient (cf. extinction-enhancing pharmacological agents that are also toxic).

Transcranial direct current stimulation (tDCS) is a safe method to induce weak transcranial currents (up to 1-2 milliampere). Using 2 rubber electrodes positioned on the scalp, tDCS can be used to manipulate localized brain excitability via membrane polarisation: cathodal stimulation hyperpolarises, while anodal stimulation depolarises the resting membrane potential, whereby the induced after-effects depend on polarity, duration and intensity of the stimulation.

The investigators believe that the therapeutic efficacy of PTSD treatment can be enhanced by employing tDCS during the therapeutic process. That is, tDCS's modulatory effects on existing brain activity may enable us to render the therapeutic mechanisms operating during trauma-focused therapy more effective, leading to a more efficient and efficacious therapeutic process in terms of greater symptom reduction, greater long-term sustainability, a shorter treatment course, and broader compliance.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of PTSD
  • Adequate physical health, including vision and hearing

Exclusion Criteria:

  • Non-trauma-related major psychiatric/neurological disorder
  • History of seizures, fainting spells, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy
  • Any metal in the brain, skull or elsewhere.
  • Pregnancy
  • Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)
  • Intracranial lesions
  • Substance abuse or dependence within the past six months
  • Other criteria for MRI/tDCS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Trauma Focused Therapy + Sham tDCS
Trauma Focused Therapy will be conducted during the delivery of sham Transcranial Direct Current Stimulation
Device: Trauma Focused Therapy + tDCS
Other Names:
  • DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118)
Active Comparator: Trauma Focused Therapy + active tDCS
Trauma focused therapy will be conducted while active Transcranial Direct Current Stimulation is applied
Device: Trauma Focused Therapy + tDCS
Other Names:
  • DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PTSD symptoms - Clinician Administered PTSD Scale (CAPS)
Time Frame: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression symptoms - Beck Depression Inventory (BDI)
Time Frame: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in depression severity (measure using Beck Depression Inventory (BDI)) - from baseline to post-treatment.
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in trait anxiety symptoms - State-Trait Anxiety Inventory (Trait subscale (STAI-Trait))
Time Frame: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in STAI-Trait scores - from baseline to post-treatment
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in state anxiety symptoms - State-Trait Anxiety Inventory (State subscale (STAI-S))
Time Frame: from baseline to post-treatment
Change in STAI-State score - from baseline to post-treatment
from baseline to post-treatment
Change in subjective quality of life - the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
Time Frame: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in WHOQOL-BREF scores - from baseline to post-treatment
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in global functioning - Global Assessment of Functioning scale (GAF)
Time Frame: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Change in GAF scores - from baseline to post-treatment
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Beth Israel Deaconess Medical Center
Tel Aviv University

Investigators

  • Principal Investigator: Talma Hendler, Prof., Tel-Aviv Sourasky Medical Center
  • Study Director: Yair Bar-Haim, Prof., Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 8, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

September 12, 2013

Last Update Submitted That Met QC Criteria

September 8, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-13-TH-334-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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