Trial Outcomes & Findings for rTMS in the Treatment of PTSD (NCT NCT01806168)

NCT ID: NCT01806168

Last Updated: 2021-04-14

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Endpoint (treatment end) (Week 2).
• Results posted on: 2021-04-14

Participant Flow

Participants were recruited from the psychiatry outpatient and community programs of Vancouver Coastal Health between 2014 and 2018. Some participants were recruited after attending an outpatient psychoeducation group but had not received formal group therapy. All assessments and treatments took place at Vancouver General Hospital in Vancouver, British Columbia, Canada.

46 patients were assessed for eligibility. 15 were excluded: 7 did not meet inclusion criteria and 8 declined to participate. The remaining 31 patients were enrolled and randomized to one of three conditions.

Participant milestones

Measure	Low-frequency (1 Hz) rTMS Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Overall Study STARTED	11	10	10
Overall Study Received Allocated Intervention	11	9	9
Overall Study COMPLETED	10	9	7
Overall Study NOT COMPLETED	1	1	3

Reasons for withdrawal

Measure	Low-frequency (1 Hz) rTMS Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	0	1	2
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Low-frequency (1 Hz) rTMS n=11 Participants Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 Participants High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 Participants Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Total n=29 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 13.5 • n=11 Participants	43.5 years STANDARD_DEVIATION 12.4 • n=9 Participants	49.5 years STANDARD_DEVIATION 6.9 • n=9 Participants	43.7 years STANDARD_DEVIATION 12.2 • n=29 Participants
Sex: Female, Male Female	10 Participants n=11 Participants	7 Participants n=9 Participants	7 Participants n=9 Participants	24 Participants n=29 Participants
Sex: Female, Male Male	1 Participants n=11 Participants	2 Participants n=9 Participants	2 Participants n=9 Participants	5 Participants n=29 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	11 Participants n=11 Participants	9 Participants n=9 Participants	9 Participants n=9 Participants	29 Participants n=29 Participants
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)	72.27 units on a scale STANDARD_DEVIATION 25.34 • n=11 Participants	69.44 units on a scale STANDARD_DEVIATION 18.29 • n=9 Participants	55.22 units on a scale STANDARD_DEVIATION 13.17 • n=9 Participants	66.10 units on a scale STANDARD_DEVIATION 21.35 • n=29 Participants

PRIMARY outcome

Timeframe: Endpoint (treatment end) (Week 2).

Population: Intention-to-treat population analysed.

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).

Outcome measures

Measure	Low-frequency (1 Hz) rTMS n=11 Participants Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 Participants High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 Participants Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)	59.80 units on a scale Standard Deviation 35.83	74.00 units on a scale Standard Deviation 30.97	65.12 units on a scale Standard Deviation 14.97

SECONDARY outcome

Timeframe: Endpoint (Week 2).

Population: Intention-to-treat population analysed.

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".

Outcome measures

Measure	Low-frequency (1 Hz) rTMS n=11 Participants Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 Participants High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 Participants Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
PTSD Checklist for Civilians (PCL-C)	48.10 score on a scale Standard Deviation 23.54	53.44 score on a scale Standard Deviation 22.80	52.14 score on a scale Standard Deviation 10.05

SECONDARY outcome

Timeframe: Endpoint (Week 2)

Population: Intent-to-treat population analysed.

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).

Outcome measures

Measure	Low-frequency (1 Hz) rTMS n=11 Participants Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 Participants High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 Participants Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Hamilton Depression Rating Scale, 21-item Version (HDRS-21)	12.30 score on a scale Standard Deviation 8.42	11.22 score on a scale Standard Deviation 7.99	14.44 score on a scale Standard Deviation 3.32

SECONDARY outcome

Timeframe: Endpoint (Week 2)

Population: Intent-to-treat population analysed.

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.

Outcome measures

Measure	Low-frequency (1 Hz) rTMS n=11 Participants Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 Participants High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 Participants Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	12.66 score on a scale Standard Deviation 6.63	15.00 score on a scale Standard Deviation 7.15	9.42 score on a scale Standard Deviation 4.68

SECONDARY outcome

Timeframe: Endpoint (Week 2)

Population: Intent-to-treat population analysed.

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.

Outcome measures

Measure	Low-frequency (1 Hz) rTMS n=11 Participants Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 Participants High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 Participants Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Beck Anxiety Inventory (BAI)	24.70 score on a scale Standard Deviation 18.19	22.77 score on a scale Standard Deviation 18.78	28.14 score on a scale Standard Deviation 10.97

SECONDARY outcome

Timeframe: Endpoint (Week 2)

Population: Intent-to-treat population.

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.

Outcome measures

Measure	Low-frequency (1 Hz) rTMS n=11 Participants Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 Participants High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 Participants Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Generalized Anxiety Disorder (GAD-7) Scale	11.90 score on a scale Standard Deviation 7.03	8.50 score on a scale Standard Deviation 8.53	11.75 score on a scale Standard Deviation 5.62

Adverse Events

Low-frequency (1 Hz) rTMS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

High-frequency (10 Hz) rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low-frequency (1 Hz) rTMS n=11 participants at risk Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	High-frequency (10 Hz) rTMS n=9 participants at risk High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2	Sham rTMS n=9 participants at risk Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2
Psychiatric disorders Suicidal Ideation	9.1% 1/11 • Number of events 1 • 6 months	0.00% 0/9 • 6 months	0.00% 0/9 • 6 months

Additional Information

Kawai Leong, MD, MSc, FRCPC

Vancouver Coastal Health / Vancouver General Hospital

Phone: 604-875-8289

Email: kawai.leong@vch.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place