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

Legion Veterans Village Research Foundation

Status and phase: Not yet enrolling; Phase 4

Conditions: Post-traumatic Stress Disorder (PTSD); Chronic Pain

Treatments: Device: Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07192536

Pro00083064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. Any sex and gender identity

3. 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

4. Able to understand the informed consent form, study procedures and willing to participate in study

5. Able to perform the testing required by the study

Exclusion criteria

1. Exhibiting significant suicide risk, as defined by:

   1. 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
   2. demonstrating suicidal behaviours or non-suicidal self-injury within the past six months, or;
   3. clinical assessment of significant suicidal risk or risk of self-injury during participant interview

2. Participants who are pregnant, nursing, or planning a pregnancy

3. 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

4. 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

5. Have participated in another clinical trial within the last 30 days or are currently enrolled in another interventional clinical trial

6. 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.

7. 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.

8. Individuals who have history of epilepsy or unexplained seizure history.

9. Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100)

10. History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure

11. Any defects in the neurocranium (e.g. after skull trepanation)

12. Skin diseases of the scalp

    Contraindications for NeuroCatch Platform:

13. Clinically documented hearing issues (e.g., in-ear hearing problems or punctured ear drum)

14. In-ear hearing aid or cochlear implant, hearing device

15. Lack of fluency in the English language

16. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Accelerated Neuromodulation Treatment

Experimental group

Description:

Intermittent theta burst stimulation (iTBS), is a non-invasive treatment that uses brief magnetic pulses to stimulate specific areas of the brain. This treatment delivers pulses in very short bursts that mimic natural brain rhythms, and may be effective in treating Post-Traumatic Stress Disorder (PTSD) and chronic pain. Each treatment takes approximately 3 minutes to complete. In this open label, single arm study, participants will undergo an accelerated treatment schedule over a period of 5 days. On day 1, participants will receive 1-2 sessions, and on days 3-5 they will receive 5-6 sessions per day (with a 45 minute break between each iTBS session).

Treatment:

Device: Transcranial magnetic stimulation