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

Q

Queen's University

Status

Completed

Conditions

Post-Traumatic Stress Disorder

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00685152
psiy-267-07

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups

Active rTMS
Experimental group
Description:
Repetitive Transcranial Magnetic Stimulation
Treatment:
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)
2
Sham Comparator group
Description:
Device: Sham (placebo)
Treatment:
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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