Status:
NOT_YET_RECRUITING
Accelerated Neuromodulation for Concurrent Post-Traumatic Stress Disorder (PTSD) & Chronic Pain in Veterans
Lead Sponsor:
Legion Veterans Village Research Foundation
Conditions:
Chronic Pain
Post-traumatic Stress Disorder (PTSD)
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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 con...
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 bur...
Eligibility Criteria
Inclusion
- Adults (\>19years age) with symptoms of both post-traumatic stress disorder (PTSD) and chronic pain, confirmed by clinical interview and rating scales (CAPS-5 \& CPGS) performed at screening visit
- a. Participants must score either 'Moderate' or 'Severe' on the CAPS-5 scale, and 'Grade I, II, or III' on the CPGS to qualify
- Any sex and gender identity
- Willing and able to attend all study visits and adhere to treatment plan, including the use of a personal computer to complete at-home questionnaires
- Able to understand the informed consent form, study procedures and willing to participate in study
- Able to perform the testing required by the study
Exclusion
- Exhibiting significant suicide risk, as defined by:
- a. suicidal ideation as indicated by items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past six months, at screening visit
- demonstrating suicidal behaviours or non-suicidal self-injury within the past six months, or;
- clinical assessment of significant suicidal risk or risk of self-injury during participant interview
- Participants who are pregnant, nursing, or planning a pregnancy
- Participants who engage in sexual intercourse which could result in pregnancy, and who do not agree to use a highly effective contraceptive method throughout their participation in the study
- Any other clinically significant neurological, psychiatric, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, vascular or any other major concurrent illness that, in the opinion of the Investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study
- Have participated in another clinical trial within the last 30 days or are currently enrolled in another interventional clinical trial
- Individuals who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators, as well as metallic implants such as electrodes, stents, clips, pins, plates, screws, braces, or other metallic objects such as shrapnel or permanent jewelry.
- The presence of ferrous metal pins or plates in or near the head (within 30 cm of the coil). Including implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, or other implants.
- Individuals who have history of epilepsy or unexplained seizure history.
- Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure \>150/100)
- History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure
- Any defects in the neurocranium (e.g. after skull trepanation)
- Skin diseases of the scalp
- Contraindications for NeuroCatch Platform:
- Clinically documented hearing issues (e.g., in-ear hearing problems or punctured ear drum)
- In-ear hearing aid or cochlear implant, hearing device
- Lack of fluency in the English language
- Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07192536
Start Date
January 1 2026
End Date
January 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
Brainstim Health
Surrey, British Columbia, Canada, V3Z 1H8