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.
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.
Israel1 site
Sourasky Medical Center
Tel Aviv
Talma Hendler, MD, talma@tasmc.health.gov.il
Orly Elchadif, orlye@tasmc.health.gov.il
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.
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- 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 group | Role | What they receive |
|---|---|---|
| Trauma Focused Therapy + Sham tDCS | Sham comparator | Trauma Focused Therapy will be conducted during the delivery of sham Transcranial Direct Current Stimulation Receives: Device: Trauma Focused Therapy + tDCS |
| Trauma Focused Therapy + active tDCS | Active comparator | Trauma 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.
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)
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)
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)
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
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)
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.
- First posted12 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University, Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
- Investigators
- Talma Hendler, Prof., Principal investigator, Tel-Aviv Sourasky Medical CenterYair Bar-Haim, Prof., Study director, Tel Aviv University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01940549
- Acronym / sponsor ID
- TASMC-13-TH-334-CTIL
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Keywords
- PTSD, tDCS, Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv University, Beth Israel Deaconess Medical Center
- Study start
- Oct 2013
- Primary completion
- Aug 2016 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Focused Therapy + Sham tDCS | Sham comparator | Device: Trauma Focused Therapy + tDCSTrauma Focused Therapy will be conducted during the delivery of sham Transcranial Direct Current Stimulation |
| Trauma Focused Therapy + active tDCS | Active comparator | Device: Trauma Focused Therapy + tDCSTrauma focused therapy will be conducted while active Transcranial Direct Current Stimulation is applied |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of PTSD
- Adequate physical health, including vision and hearing
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Focused Therapy + tDCSAlso: DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118) | Device | Trauma Focused Therapy + Sham tDCS, Trauma Focused Therapy + active tDCS |
Primary outcome
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
5 secondary outcomes
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 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 state anxiety symptoms - State-Trait Anxiety Inventory (State subscale (STAI-S))
Time frame: 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 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talma Hendler, Prof. principal investigator
Tel-Aviv Sourasky Medical Center
Yair Bar-Haim, Prof. study director
Tel Aviv University
1 site in 1 country: see every site and its status.
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.