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Chronic PainPhase 4ANCHORNCT07192536

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

A Phase 4 study testing Transcranial magnetic stimulation in people with Chronic Pain and Post-traumatic Stress Disorder (PTSD), run by Legion Veterans Village Research Foundation at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Transcranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
Jan 2026to Jan 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cyrana C Gallay, MSc, PhD Candidate contact

360-820-3451

research@brainstim.ca

Canada1 site
  • Brainstim Health

    Surrey, British Columbia, V3Z 1H8

Other trials in Canada

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Transcranial magnetic stimulation
Keywords
Transcranial Magnetic Stimulation (TMS), PTSD, chronic pain, Veterans, Theta burst stimulation, Brain stimulation, Neuromodulation, Military, Accelerated treatment protocol
Medical subject headings
Chronic Pain, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial magnetic stimulationDevice

    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.

Study groups in NCT07192536
Study groupRoleWhat they receive
Accelerated Neuromodulation TreatmentExperimentalIntermittent 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).
Receives: Device: Transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) score

    The PCL-5 is a 20-item self-report checklist of Post-Traumatic Stress Disorder (PTSD) symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms. A score greater than 33 is typically used to indicate severity sufficient for a PTSD diagnosis

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  2. Change in Chronic Pain Grade Scale (CPGS) score

    The CPGS assesses two dimensions of overall chronic pain severity: pain intensity and pain-related disability. It is suitable for use in all chronic pain conditions. Participants must score 'Grade I, II, or III' on the CPGS at screening to qualify for the study. Each questions is scored using a 11-point Likert scale. Total scores range from 0 to 30, with higher scores indicating more pain.

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  3. Change in Pain Disability Index (PDI) score

    The PDI is designed to measure the degree to which aspects of a participant's life are disrupted by chronic pain. In other words, how much pain is preventing them from doing what they would normally do or from doing it as well as they normally would. Participants will be asked to respond to each category indicating the overall impact of pain in their life, not just when pain is at its worst. The total PDI score can range from 0 to 70, a higher score indicating more disruption with functioning across a range of activities.

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

Secondary outcomes (10)
  1. Change in Hamilton Depression Rating Scale (HAM-D) score

    The Hamilton Depression Rating Scale (HAM-D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  2. Change in Patient Health Questionnaire (PHQ-9) score

    The PHQ-9 is a 9-item self-report questionnaire used to assess depression symptom severity. Depression symptoms are rated from 0 (not depression) to 27 (severe).

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  3. Change in Hamilton Anxiety Rating Scale (HAM-A) score

    The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 (no anxiety) to 56 (severe anxiety)

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  4. Change in General Anxiety Disorder scale (GAD-7) score

    The General Anxiety Disorder scale is a 7-item questionnaire used to measure symptoms of generalized anxiety disorder. Scores range from 0-21 with higher scores indicating more generalized anxiety

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  5. Change in Inventory of Psychosocial functioning (IPF) score

    The IPF is a self-report instrument measuring PTSD-related functional impairment experienced by Veterans. Respondents rate how often they have acted a certain way over the past 30 days. The IPF was developed to have high content validity, to not confound PTSD symptoms and related impairment, and to not require respondent attributions regarding the cause of impairment. Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). The IPF yields a total score (0-66) and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning (lower indicates better functioning/less impairment). Higher scores indicate more impairment

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  6. ReadON Cognitive Test

    Cognitive function, specifically executive functioning, processing speed, episodic memory, and working memory, will be assessed using the ReadON Cognitive Test (Orange Neurosciences, Kingston, ON, Canada). Unlike standardized paper tests with a single total score, the ReadON test uses an algorithm to provide a comprehensive profile across multiple cognitive domains.

    Measured: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)

  7. NeuroCatch® Platform

    NeuroCatch® Platform (NCP; NeuroCatch Inc., Surrey, BC, Canada) will be used to complement as an objective measure of cognitive function. NCP is an easy-to-use, objective, rapid neuro-physiological brain function assessment system, licensed by Health Canada as a Class II medical device. The platform provides acquisition, display, analysis, storage, reporting, and management of EEG and event related potential (ERP) information including the N100, P300 and N400 measures of brain function

    Measured: From baseline visit to end of treatment visit (end of week 1)

  8. Program Feasibility will be assessed using the Effectiveness Framework

    Efficacy/effectiveness will be assessed using results from the clinician- and participant-reported Post-Traumatic Stress Disorder (PTSD) and chronic pain symptoms measured as primary outcome measures (PCL-5 and CPGS), comparing changes from baseline to end of treatment (end of week 1).

    Measured: Through study completion, an average of 1 year

  9. Program Feasibility will be assessed using the Adoption Framework

    Adoption will be assessed as the perceived ease of protocol administration (for clinicians) and program adherence (for participants).

    Measured: Through study completion, an average of 1 year

  10. Program Feasibility will be assessed using the Implementation and Maintenance framework

    Implementation and maintenance will be assessed upon qualitative reports from the study team and participants regarding barriers and facilitators to help inform future program implementation efforts

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This preliminary clinical study is an open label, non-randomized, single group, proof of concept design.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192536
Sponsor's protocol ID
Pro00083064
Acronym
ANCHOR
Status last verified
Sep 2025
First submitted
31 Aug 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Transcranial magnetic stimulation in people with Chronic Pain and Post-traumatic Stress Disorder (PTSD), run by Legion Veterans Village Research Foundation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cyrana C Gallay, MSc, PhD Candidate (360-820-3451, research@brainstim.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) score (time frame: Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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ANCHOR Clinical Trial NCT07192536 | AzTrials