NCT07192536

Accelerated Neuromodulation for Concurrent Post-Traumatic Stress Disorder (PTSD) & Chronic Pain in Veterans

Accelerated Neuromodulation for Concurrent Post-Traumatic Stress Disorder (PTSD) & Chronic Pain in Veterans - Exploring Preliminary Efficacy and Feasibility

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Legion Veterans Village Research Foundation · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The ANCHOR study is testing a novel, non-invasive brain stimulation program designed specifically for Veterans experiencing concurrent post-traumatic stress disorder (PTSD) and chronic pain. These conditions often occur together and can greatly impact daily life. Current treatments options for PTSD and chronic pain are limited, may come with severe side-effects, and often take weeks if not months to see results. In this study, participants will receive an intensive one-week course of intermittent theta burst stimulation (iTBS), a Health Canada-approved technology already used for depression. In this study, it is being tested for its potential to reduce both PTSD and chronic pain symptoms. This clinical trial will recruit 30 Veterans, all of whom will receive the active treatment (there is no placebo). Participants will receive 5-6 sessions of iTBS per day (each treatment lasts approximately 3 minutes) over a period of 5 days (one week total duration). Researchers will track changes in PTSD symptoms, chronic pain, mood, anxiety, daily functioning, and cognitive performance at 4 time points: baseline (before treatment), at the end of treatment ( end of week 1), and at 2 follow-up assessments (3 weeks and 6 weeks after the end of treatment). The goal of this study is to determine whether this unique brain stimulation program is able to treat concurrent PTSD and chronic pain in Canadian Veterans. This study also aims to lay the groundwork for larger trials that could expand access to innovative treatments for the Veteran community.

Detailed description

This is an open label, non-randomized, single group, proof of concept design study. Military Veterans experiencing concurrent PTSD and chronic pain will undergo an an intensive one-week rTMS theta burst protocol with multiple stimulation session per day. Follow-up assessments will take place 3-weeks and 6-weeks post final treatment.

Conditions

• Chronic Pain
• Post-traumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
DEVICE	Transcranial magnetic stimulation	Intermittent theta burst stimulation (iTBS) will be delivered via the Magstim Horizon 3.0 Transcranial Magnetic Stimulation device. This device has been authorized by Health Canada (License No.: 111334, Type: System, Device class: 3 Device first issue date 2024-06-04, License name: HORIZON 3.0 TMS THERAPY SYSTEM) and is indicated for use in treating mild depressive disorder. The device will be used off-label as a potential treatment for Post-Traumatic Stress Disorder (PTSD) and chronic pain in this Investigator-Initiated study. rTMS will be delivered using modified intermittent theta burst accelerated bilateral treatments (MITAB), combining low frequency 1HZ to the right dorsolateral prefrontal cortex (dlPFC) with high frequency intermittent theta burst to the left dlPFC, up to 6 times per day for 5 days.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2025-09-25
• Last updated: 2025-11-18

Locations

1 site across 1 country: Canada