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rTMS for PTSD Comorbid With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273063
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
Providence VA Medical Center
Neuronetics
Information provided by (Responsible Party):
Butler Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Posttraumatic Stress Disorder
Major Depressive Disorder
Transcranial Magnetic Stimulation, Repetitive
Intervention Device: Transcranial Magnetic Stimulation (TMS)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TMS Prescription
Hide Arm/Group Description

5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000

Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
Period Title: Overall Study
Started 40
Completed 35
Not Completed 5
Arm/Group Title TMS Prescription
Hide Arm/Group Description

5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000

Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
Comorbid PTSD & MDD
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
51.6  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
14
  40.0%
Male
21
  60.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 35 participants
White
33
  94.3%
Black
1
   2.9%
Multiracial
1
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Total Score on PTSD Checklist for DSM-5 (PCL-5)
Hide Description This self-report scale is called: "PTSD Checklist for DSM-5" (abbreviated PCL-5) (see https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp). Total PCL-5 score ranges from 0 to 80. Analysis of treatment effect on symptom severity will be evaluated by change in PCL-5 total score from baseline (pre-TMS) to endpoint (post-TMS)(or LOCF); Paired t-test compares the mean total PCL-score for the group at the two time points. A higher total score on the PCL-5 scale corresponds with more severe PTSD symptoms than a lower total score. A greater change from baseline to endpoint would correspond with better treatment outcome.
Time Frame Baseline to final TMS session (up to 40 sessions over up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat population
Arm/Group Title Transcranial Magnetic Stimulation (TMS)
Hide Arm/Group Description:

TMS 5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000

Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
BASELINE 52.2  (13.1)
ENDPOINT 34.0  (21.6)
2.Primary Outcome
Title Total Score on Inventory of Depressive Symptomatology, Self-Report (IDS-SR) Scale
Hide Description This self-report scale is called "Inventory of Depressive Symptomatology, Self-Report" (Abbreviated IDS-SR). IDS-SR Total Scores Range from 0 to 84, with a higher score reflecting greater depressive symptom severity. Paired t-test compares the change in mean total IDS-SR score from baseline (pre-TMS) to endpoint (last TMS session) or LOCF. A greater change reflects a better outcome than lesser change.
Time Frame Baseline to final TMS session (up to 40 sessions over up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat population
Arm/Group Title TMS Prescription
Hide Arm/Group Description:

5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000

Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
BASELINE 47.8  (11.9)
ENDPOINT 30.9  (18.9)
Time Frame baseline to endpoint (week 10 or LOCF).
Adverse Event Reporting Description Adverse event data collected through (1) Response of participants to queries by study clinicians during treatment sessions and during study-specific assessment visits (2) spontaneous reports initiated by participants.
 
Arm/Group Title TMS Prescription
Hide Arm/Group Description

5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000

Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment.
All-Cause Mortality
TMS Prescription
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
TMS Prescription
Affected / at Risk (%) # Events
Total   4/35 (11.43%)    
Psychiatric disorders   
Psychiatric Hospitalization *  4/35 (11.43%)  4
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TMS Prescription
Affected / at Risk (%) # Events
Total   15/35 (42.86%)    
Nervous system disorders   
migraine *  1/35 (2.86%)  1
Psychiatric disorders   
Activation/insomnia/irritability *  14/35 (40.00%)  14
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director
Organization: Neuromodulation Research Clinic
Phone: 401-455-6200
EMail: Linda_Carpenter_MD@Brown.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT02273063    
Other Study ID Numbers: 1404-005
First Submitted: October 15, 2014
First Posted: October 23, 2014
Results First Submitted: May 9, 2018
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018