NCT01940549

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

2.8 years

First QC Date

September 2, 2013

Last Update Submit

September 8, 2013

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

PTSDtDCSTrauma

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD symptoms - Clinician Administered PTSD Scale (CAPS)

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

    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)

    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))

    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))

    from baseline to post-treatment

  • Change in subjective quality of life - the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

    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)

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

Study Arms (2)

Trauma Focused Therapy + Sham tDCS

SHAM COMPARATOR

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

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

Device: Trauma Focused Therapy + tDCS

Interventions

Trauma Focused Therapy + tDCSDEVICE
Also known as: DC-STIMULATOR PLUS (neuroConn GmbH, serial 0118)
Trauma Focused Therapy + Sham tDCSTrauma Focused Therapy + active tDCS

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Talma Hendler, Prof.

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Yair Bar-Haim, Prof.

    Tel Aviv University

    STUDY DIRECTOR

Central Study Contacts

Yair Bar-Haim, PhD

CONTACT

03-6405465yair1@post.tau.ac.il

Talma Hendler, MD

CONTACT

03-6973953talma@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Research & Development

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 12, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2016

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

IL(1)