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

Primary Purpose

Post-traumatic Stress Disorder (PTSD)

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Trauma Focused Therapy + tDCS
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder (PTSD) focused on measuring PTSD, tDCS, Trauma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Trauma Focused Therapy + Sham tDCS

Trauma Focused Therapy + active tDCS

Arm Description

Trauma Focused Therapy will be conducted during the delivery of sham Transcranial Direct Current Stimulation

Trauma focused therapy will be conducted while active Transcranial Direct Current Stimulation is applied

Outcomes

Primary Outcome Measures

Change in PTSD symptoms - Clinician Administered PTSD Scale (CAPS)
Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment

Secondary Outcome Measures

Change in depression symptoms - Beck Depression Inventory (BDI)
Change in depression severity (measure using Beck Depression Inventory (BDI)) - from baseline to post-treatment.
Change in trait anxiety symptoms - State-Trait Anxiety Inventory (Trait subscale (STAI-Trait))
Change in STAI-Trait scores - from baseline to post-treatment
Change in state anxiety symptoms - State-Trait Anxiety Inventory (State subscale (STAI-S))
Change in STAI-State score - from baseline to post-treatment
Change in subjective quality of life - the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
Change in WHOQOL-BREF scores - from baseline to post-treatment
Change in global functioning - Global Assessment of Functioning scale (GAF)
Change in GAF scores - from baseline to post-treatment

Full Information

First Posted
September 2, 2013
Last Updated
September 8, 2013
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Tel Aviv University, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01940549
Brief Title
Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress Disorder
Official Title
Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Tel Aviv University, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder (PTSD)
Keywords
PTSD, tDCS, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trauma Focused Therapy + Sham tDCS
Arm Type
Sham Comparator
Arm Description
Trauma Focused Therapy will be conducted during the delivery of sham Transcranial Direct Current Stimulation
Arm Title
Trauma Focused Therapy + active tDCS
Arm Type
Active Comparator
Arm Description
Trauma focused therapy will be conducted while active Transcranial Direct Current Stimulation is applied
Intervention Type
Device
Intervention Name(s)
Trauma Focused Therapy + tDCS
Other Intervention Name(s)
DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118)
Primary Outcome Measure Information:
Title
Change in PTSD symptoms - Clinician Administered PTSD Scale (CAPS)
Description
Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment
Time Frame
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Secondary Outcome Measure Information:
Title
Change in depression symptoms - Beck Depression Inventory (BDI)
Description
Change in depression severity (measure using Beck Depression Inventory (BDI)) - from baseline to post-treatment.
Time Frame
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Title
Change in trait anxiety symptoms - State-Trait Anxiety Inventory (Trait subscale (STAI-Trait))
Description
Change in STAI-Trait scores - from baseline to post-treatment
Time Frame
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Title
Change in state anxiety symptoms - State-Trait Anxiety Inventory (State subscale (STAI-S))
Description
Change in STAI-State score - from baseline to post-treatment
Time Frame
from baseline to post-treatment
Title
Change in subjective quality of life - the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
Description
Change in WHOQOL-BREF scores - from baseline to post-treatment
Time Frame
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)
Title
Change in global functioning - Global Assessment of Functioning scale (GAF)
Description
Change in GAF scores - from baseline to post-treatment
Time Frame
One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Bar-Haim, PhD
Phone
03-6405465
Email
yair1@post.tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Talma Hendler, MD
Phone
03-6973953
Email
talma@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talma Hendler, Prof.
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, Prof.
Organizational Affiliation
Tel Aviv University
Official's Role
Study Director
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talma Hendler, MD
Email
talma@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Orly Elchadif
Email
orlye@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Talma Hendler, MD

12. IPD Sharing Statement

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

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