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High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

Primary Purpose

Post-Traumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed Patient Information and Consent.
Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR.
Patients with CAPS score of at least 40.
Males or females between 18-65 years of age.
Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase.
Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.

Exclusion Criteria:

Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder.
Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study.
Patients with HDRS score ≥ 18.
A metallic implant in cranium (except the mouth).
Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety.
ECT treatment within the last three months.
Patients with a history of epilepsy.
Patients with neurological disorder leading to increased intracranial pressure.
Patients with severe cardiac disorder or intracardiac lines and pacemakers.
Patients with current suicide risk ≥ 6 points by MINI.

Sites / Locations

Dr. Dancho Dilkov
Providence Care Mental Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active rTMS

Arm Description

Repetitive Transcranial Magnetic Stimulation

Device: Sham (placebo)

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS) in both active and sham groups

Secondary Outcome Measures

Treatment Outcome PTSD scale (TOP-8)

Hamilton Anxiety Scale

Hamilton Depression Rating Scale

Clinical Global Impression Scale (both severity and improvement)

Social Functioning-36 Quality of Life Scale version(1)

Pittsburgh Sleep Quality Index

PTSD Checklist-civilian (PCL-C)

Full Information

NCT ID

NCT00685152

First Posted

May 8, 2008

Last Updated

December 14, 2015

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT00685152

Brief Title

High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

Official Title

High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS

Arm Type

Experimental

Arm Description

Repetitive Transcranial Magnetic Stimulation

Arm Title

Arm Type

Sham Comparator

Arm Description

Device: Sham (placebo)

Intervention Type

Device

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

Other Intervention Name(s)

rTMS machine (MagPro, Medtronic).

Intervention Description

6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.

Primary Outcome Measure Information:

Title

Clinician Administered PTSD Scale (CAPS) in both active and sham groups

Time Frame

pre, week 2,4,6,8 & 12

Secondary Outcome Measure Information:

Title

Treatment Outcome PTSD scale (TOP-8)

Time Frame

Pre, week 2,4,6,8 & 12

Title

Hamilton Anxiety Scale

Time Frame

Pre, week 2,4,6,8 & 12

Title

Hamilton Depression Rating Scale

Time Frame

Pre, week 2,4,6,8 & 12

Title

Clinical Global Impression Scale (both severity and improvement)

Time Frame

Pre, week 2,4,6,8 & 12

Title

Social Functioning-36 Quality of Life Scale version(1)

Time Frame

Pre, week 2,4,6,8 & 12

Title

Pittsburgh Sleep Quality Index

Time Frame

Pre, week 2,4,6,8 & 12

Title

PTSD Checklist-civilian (PCL-C)

Time Frame

Pre, week 2,4,6,8 & 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed Patient Information and Consent. Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR. Patients with CAPS score of at least 40. Males or females between 18-65 years of age. Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase. Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase. Exclusion Criteria: Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder. Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study. Patients with HDRS score ≥ 18. A metallic implant in cranium (except the mouth). Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety. ECT treatment within the last three months. Patients with a history of epilepsy. Patients with neurological disorder leading to increased intracranial pressure. Patients with severe cardiac disorder or intracardiac lines and pacemakers. Patients with current suicide risk ≥ 6 points by MINI.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roumen Milev, MD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Dancho Dilkov

City

Sofia

Country

Bulgaria

Facility Name

Providence Care Mental Health Services

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 4X3

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

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