Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study will test the clinical efficacy of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Adults age 18 years to 65 years old.
• Meets DSM-5 criteria for PTSD with a PCL-5 score \> 33
• No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.
• Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
Locations
United States
Florida
Florida State University
RECRUITING
Tallahassee
Contact Information
Primary
Isabelle M Taylor, MA
fsun@fsu.edu
850-644-2824
Backup
Kevin A Johnson, PhD
fsun@fsu.edu
850-644-2824
Time Frame
Start Date: 2024-11-06
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 132
Treatments
Active_comparator: Arm 1: active left dl-PFC accel-TMS
Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
Active_comparator: Arm 2:active dm-PFC accel-TMS
Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
Sham_comparator: Arm 3 - sham accel-TMS dl-PFC
Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
Sham_comparator: Arm 4: sham accel -TMS dm-PFC
Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
Active_comparator: Arm 5
Extension phase, all participants will receive active left dl-PFC accel-TMS.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Florida State University