rTMS in the Treatment of PTSD

Post-traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806168
• Other study ID #: H12-01578
• Secondary ID: V12-01578
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 2019

Study information

• Verified date: March 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• primary diagnosis of PTSD as determined by a structured interview using the Mini International Neuropsychiatric Interview (MINI)
• no change in psychotropic medications within 4 weeks before the start of rTMS
• age > 19 years and < 70 years
• competency to give informed consent

Exclusion Criteria:

• any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rTMS coil
• implantable devices, including cardiac pacemakers and defibrillators
• other contraindications to rTMS, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy
• psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type I disorder, or organic mental disorders
• substance abuse/dependence within the past 3 months
• active suicidal risk as judged by the clinician
• borderline or antisocial personality disorder
• acute medical illness, including cancer
• any significant central nervous system disorder, such as brain mass, stroke, etc.

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• rTMS
Magstim Super Rapid-2

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)	The Clinician-Administered PTSD Scale-IV (CAPS-IV) is a semi-structured instrument that assesses the intensity, frequency, and severity of PTSD symptoms. It consists of 17 symptom items, each rated on a 0-4 scale for frequency and a 0-4 scale for intensity, with higher scores indicating greater frequency/intensity. The frequency and intensity scores are then summed to yield a total item severity score (range 0-8). The minimum score of the overall scale is 0 and maximum is 17 items * maximum severity score of 8 = 136 (higher scores indicating more severe symptoms).	Endpoint (treatment end) (Week 2).
Secondary	PTSD Checklist for Civilians (PCL-C)	The PTSD Checklist for Civilians (PCL-C) is a standardised self-report rating scale for PTSD comprising 17 items that correspond to the DSM-V symptoms of PTSD. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely".	Endpoint (Week 2).
Secondary	Hamilton Depression Rating Scale, 21-item Version (HDRS-21)	A clinician-rated assessment of depression symptoms consisting of 21 items rated on a scale from 0 to 4, 0 to 2, or 0 to 3, with higher scores indicating greater symptom severity in all cases. Minimum score = 0; maximum score = 53 (scores > 23 are considered to be severe).	Endpoint (Week 2)
Secondary	Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	A self-report scale to assess symptoms of depression consisting of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted). Scores range from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-27, with scores >= 21 considered very severe, 20-16 severe, 11-15 moderate, and 6-10 mild depression.	Endpoint (Week 2)
Secondary	Beck Anxiety Inventory (BAI)	A self-report scale to assess symptoms of anxiety, consisting of 21 items scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-63, with scores >= indicating potentially concerning levels of anxiety.	Endpoint (Week 2)
Secondary	Generalized Anxiety Disorder (GAD-7) Scale	A brief self-report scale to assess symptoms of anxiety, consisting of 7 items each scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-21, with scores 0-4 suggesting minimal anxiety, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety.	Endpoint (Week 2)