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

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ClinicalTrials.gov Identifier: NCT01940549
Recruitment Status : Unknown
Verified September 2013 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2013
Last Update Posted : September 12, 2013
Sponsor:
Collaborators:
Tel Aviv University
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder (PTSD) Device: Trauma Focused Therapy + tDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress Disorder
Study Start Date : October 2013
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940549


Contacts
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Contact: Yair Bar-Haim, PhD 03-6405465 yair1@post.tau.ac.il
Contact: Talma Hendler, MD 03-6973953 talma@tasmc.health.gov.il

Locations
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Israel
Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Talma Hendler, MD       talma@tasmc.health.gov.il   
Contact: Orly Elchadif       orlye@tasmc.health.gov.il   
Principal Investigator: Talma Hendler, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Tel Aviv University
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Talma Hendler, Prof. Tel-Aviv Sourasky Medical Center
Study Director: Yair Bar-Haim, Prof. Tel Aviv University

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Responsible Party: Michal Roll PhD,MBA, Director, Division of Research & Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01940549     History of Changes
Other Study ID Numbers: TASMC-13-TH-334-CTIL
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Keywords provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:
PTSD
tDCS
Trauma

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders