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

NCT ID: NCT01940549

Last Updated: 2013-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31

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.

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

PTSD; tDCS; Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trauma Focused Therapy + Sham tDCS

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

Group Type: SHAM_COMPARATOR

Trauma Focused Therapy + tDCS

Intervention Type: DEVICE

Trauma Focused Therapy + active tDCS

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

Group Type: ACTIVE_COMPARATOR

Trauma Focused Therapy + tDCS

Intervention Type: DEVICE

Interventions

Trauma Focused Therapy + tDCS

Intervention Type: DEVICE

Other Intervention Names

DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michal Roll PhD,MBA

Director, Division of Research & Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talma Hendler, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Yair Bar-Haim, Prof.

Role: STUDY_DIRECTOR

Tel Aviv University

Locations

Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Yair Bar-Haim, PhD

Role: CONTACT

Phone: 03-6405465

Email: yair1@post.tau.ac.il

Talma Hendler, MD

Role: CONTACT

Phone: 03-6973953

Email: talma@tasmc.health.gov.il

Facility Contacts

Talma Hendler, MD

Role: primary

Orly Elchadif

Role: backup

Other Identifiers

TASMC-13-TH-334-CTIL

Identifier Type: -

Identifier Source: org_study_id