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Post-traumatic Stress Disorder (PTSD)NCT01940549

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

A study testing Trauma Focused Therapy + tDCS in people with Post-traumatic Stress Disorder (PTSD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Post-traumatic Stress Disorder (PTSD)
What is being tested?
Trauma Focused Therapy + tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteIsrael
Study dates
Oct 2013to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Yair Bar-Haim, PhD contact

03-6405465

yair1@post.tau.ac.il

Talma Hendler, MD contact

03-6973953

talma@tasmc.health.gov.il

Israel1 site
  • Sourasky Medical Center

    Tel Aviv

    Talma Hendler, MD, talma@tasmc.health.gov.il

    Orly Elchadif, orlye@tasmc.health.gov.il

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Trauma Focused Therapy + tDCS
Keywords
PTSD, tDCS, Trauma
Medical subject headings
Stress Disorders, Post-Traumatic, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma Focused Therapy + tDCSDevice

    Also called DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118)

Study groups in NCT01940549
Study groupRoleWhat they receive
Trauma Focused Therapy + Sham tDCSSham comparatorTrauma Focused Therapy will be conducted during the delivery of sham Transcranial Direct Current Stimulation
Receives: Device: Trauma Focused Therapy + tDCS
Trauma Focused Therapy + active tDCSActive comparatorTrauma focused therapy will be conducted while active Transcranial Direct Current Stimulation is applied
Receives: Device: Trauma Focused Therapy + tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in PTSD symptoms - Clinician Administered PTSD Scale (CAPS)

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

    Measured: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

Secondary outcomes (5)
  1. Change in depression symptoms - Beck Depression Inventory (BDI)

    Change in depression severity (measure using Beck Depression Inventory (BDI)) - from baseline to post-treatment.

    Measured: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

  2. Change in trait anxiety symptoms - State-Trait Anxiety Inventory (Trait subscale (STAI-Trait))

    Change in STAI-Trait scores - from baseline to post-treatment

    Measured: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

  3. Change in state anxiety symptoms - State-Trait Anxiety Inventory (State subscale (STAI-S))

    Change in STAI-State score - from baseline to post-treatment

    Measured: from baseline to post-treatment

  4. 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

    Measured: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

  5. Change in global functioning - Global Assessment of Functioning scale (GAF)

    Change in GAF scores - from baseline to post-treatment

    Measured: One week before treatment start (baseline measure), and up to 4 weeks after treatment end (post measure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionAug 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940549
Sponsor's protocol ID
TASMC-13-TH-334-CTIL
Status last verified
Sep 2013
First submitted
2 Sep 2013
Last updated
12 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Trauma Focused Therapy + tDCS in people with Post-traumatic Stress Disorder (PTSD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yair Bar-Haim, PhD (03-6405465, yair1@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.

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