Viewing Study NCT02158663



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Last Modification Date: 2024-10-26 @ 11:25 AM
Study NCT ID: NCT02158663
Status: COMPLETED
Last Update Posted: 2020-04-27
First Post: 2014-05-30

Brief Title: Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder PTSD
Sponsor: James A Haley Veterans Administration Hospital
Organization: James A Haley Veterans Administration Hospital

Study Overview

Official Title: Randomized Trial of 1 Hz Versus 10 Hz Right Prefrontal Repetitive Transcranial Magnetic Stimulation rTMS for the Treatment of Posttraumatic Stress Disorder PTSD
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Objectives The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score The secondary objectives include one testing which treatment provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score two testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms three testing which treatment is better tolerated as measured by participant drop out and side effect profiles

Research Design Randomized single-blind raters prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD

Methodology Veterans 18-50 years of age suffering from PTSD with and without depressive symptoms will be recruited from the community as well as mental health clinics at James A Haley Veterans Administration Hospital Plan to enroll 50 to have an evaluable sample of approximately 20 in each group Participants will be consented and undergo screening for safety and appropriateness to be in the trial Those deemed eligible will be evaluated with clinical measures of function PTSD depression pain and neurobehavioral symptoms Participants will be randomized in equal proportion stratified by significant depression defined as MADRS greater than 19 to one of two active treatments right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS Participants will undergo assessment for safety prior to each treatment The treatments will be performed 5 days a week for 6 weeks with a 3-week taper consisting of 3 days per week 2 days per week and 1 day per week Clinical evaluations will be performed at baseline after every five treatments at the end of treatment and at 1 and 3 months post treatment CAPS and IPF scores will be used to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal rTMS for PTSD symptoms and function respectively The QIDS scores will be used to test for a significant difference in change in depressive symptoms for both the participants with significant depressive symptoms and the entire group The number of dropouts related specifically to side effects and all cause will be used along with side effect profiles to test for differences in tolerability of the two treatments
Detailed Description: Participants wishing to participate will contact the study team either personally or through their provider at the Veterans request Further means of recruitment are as follows 1 Flyers will be placed at the University of South Florida and other high learning institutions in the local area 2The study team will provide flyers and give talks at Veteran associated organizations 3The study will also be advertised on the JAH Facebook page as well as the JAH Twitter account 4 Veterans with a PTSD diagnosis will be identified using the VSSC web reports Using this method the study staff will pre-screen the CPRS records of 5000 veterans to identify potential subjects The identified veterans will be sent a recruitment letter with detailed information about the study as well as a copy of the informed consent After a 10-day waiting period the study team will them contact the veteran by phone to see if they are interested in participating The study team will review the Veterans medical record and discuss the study and its entry criteria with the participants andor provider Those suitable to enter the trial and interested will be scheduled for a screeningbaseline visit These participants will typically be those who have either failed or are not willing to engage in standard evidence-based psychotherapy

The screeningbaseline visit will begin by acquiring written informed consent Subsequently evaluations to determine safety and appropriateness as well as clinical ratings and laboratory testing UDS and urine pregnancy testing will be performed Those deemed eligible will be randomized to 1 Hz versus 10 Hz stratified by significant depression MADRS 19 and treated on a subsequent day within a week Participants will be treated for 5 days a week for 6 weeks with a 3-week taper 3 per week for 1 week 2 per week for 1 week 1 per week for 1 week Participants will undergo clinical evaluation weekly for clinical effect during the treatment at the end of the taper or when participant chooses to leave the trial and at 1- and 3-months post treatment In addition safety will be assessed prior to each treatment The total time in study for a participant will be approximately 22 weeks

Randomization will be stratified based on significant depressive symptoms which will be defined as a MADRS score 19 versus MADRS score 19 Using a computer randomization schedule an investigator not involved directly with the trial will generate two random lists of active and sham cards that will be placed in envelopes The two groups will be MADRS score 19 versus MADRS score 19 When the participant is ready to begin the first treatment the treater will pull the next envelope in line for the appropriate group and open the envelope to determine the randomization assignment The participant will know the assignment as well as the treater but the investigator doing all the clinician rating scales will be masked to assignment

Medications and other treatments Participants will be allowed to continue current medications and therapy as long as does not increase risk of rTMS and is held constant during the six weeks of the trial Doses may be adjusted as need for side effects

Materials obtained for research purposes include demographic information contact information for purposes of the study only medicalpsychiatric history from interviews questionnaires cognitive test data laboratory data and clinical data All of the data will be obtained for research purposes

Treatment with the Neurostar Repetitive Transcranial Magnetic Stimulation Stimulation System may involve other risks that are not known at the present time The long-term effects of rTMS Repetitive Transcranial Magnetic Stimulation are not known Legal and social risks of participation in this research are unknown

The PI will monitor the safety of the participants to continue in the trial The PI will be seeing the participants in person typically on at least a weekly basis The PI will review the study data for side effects on an ongoing basis but more formally every 12 months to ensure no trends in the data of increased risk

The data will only be used by the research team within the VA to address the research questions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None