Transcranial Magnetic Stimulation for PTSD and Chronic Pain

(ANCHOR Trial)

Overseen By Cyrana C Gallay, MSc, PhD Candidate

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Legion Veterans Village Research Foundation

Disqualifiers: Suicide risk, Pregnancy, Neurological, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist Veterans dealing with both post-traumatic stress disorder (PTSD) and chronic pain. It employs intermittent theta burst stimulation (iTBS), which uses short magnetic pulses to stimulate the brain and is already used for depression. The goal is to determine if this method can quickly reduce symptoms of PTSD and chronic pain without the long wait or side effects of current treatments. Veterans with both PTSD and chronic pain who can attend all study sessions might be suitable candidates for this trial. As a Phase 4 trial, the research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for Intermittent Theta Burst Stimulation (iTBS)?

Research shows that intermittent theta burst stimulation (iTBS) is a promising treatment. Already approved in Canada for depression, it is generally safe. Studies have found that iTBS can effectively reduce PTSD (post-traumatic stress disorder) symptoms without major side effects. This treatment uses brief magnetic pulses to stimulate specific brain areas and is non-invasive, meaning it doesn't involve surgery or entering the body.

Additionally, research suggests that iTBS is as effective as traditional methods like repetitive transcranial magnetic stimulation (rTMS) for treating PTSD, further supporting its safety. The treatment is quick, making it less time-consuming and potentially more convenient for participants.

Overall, while every treatment has some risks, existing data on iTBS suggests it is well-tolerated with no major adverse events reported in studies. Participants in this trial can feel reassured by the safety record of iTBS so far. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for PTSD and chronic pain, which often involve medications or lengthy therapy sessions, Intermittent Theta Burst Stimulation (iTBS) is unique because it uses brief magnetic pulses to stimulate specific brain areas. This non-invasive technique mimics natural brain rhythms and could offer rapid relief, with sessions taking only about 3 minutes each. Researchers are excited because iTBS has the potential to show improvements in just a few days, contrasting with traditional treatments which may take weeks or even months to demonstrate effectiveness.

What evidence suggests that this brain stimulation program is effective for PTSD and chronic pain?

Research has shown that intermittent theta burst stimulation (iTBS), which participants in this trial will receive, can effectively improve PTSD symptoms, offering benefits similar to other brain stimulation methods. Studies have found that more iTBS sessions lead to better results, particularly in reducing symptoms like anger. For chronic pain, iTBS imitates natural brain rhythms and shows promise, although more research is needed to fully understand its effects. Since iTBS is already approved for treating depression, there is hope it can also help with PTSD and chronic pain. This treatment is non-invasive and quick, making it a promising option for those seeking relief from these challenging conditions. ^{5 6 7 8 9}

Who Is on the Research Team?

Venugopal Karapereddy, FRCP(C)

Principal Investigator

University of British Columbia (UBC); Brainstim Health;

Are You a Good Fit for This Trial?

The ANCHOR study is for Canadian Veterans suffering from both PTSD and chronic pain. Participants must be able to attend daily sessions for one week and commit to follow-up assessments. Specific inclusion or exclusion criteria are not provided, but typically these would involve factors like age range, severity of symptoms, and absence of conditions that could interfere with the treatment or skew results.

Inclusion Criteria

I can do the tests needed for the study.

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

My gender identity does not affect my eligibility.

Exclusion Criteria

Exhibiting significant suicide risk, as defined by: 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intensive one-week course of intermittent theta burst stimulation (iTBS), with 5-6 sessions per day over 5 days

1 week

5 days of treatment with multiple sessions per day

Follow-up

Participants are monitored for changes in PTSD symptoms, chronic pain, mood, anxiety, daily functioning, and cognitive performance

6 weeks

2 follow-up assessments at 3 weeks and 6 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Theta Burst Stimulation (iTBS)

Trial Overview This trial tests a non-invasive brain stimulation technique called intermittent theta burst stimulation (iTBS) over one week to reduce PTSD and chronic pain symptoms in Veterans. All participants will receive active treatment without a placebo group, undergoing multiple short iTBS sessions per day.

How Is the Trial Designed?

Group I: Accelerated Neuromodulation Treatment Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Legion Veterans Village Research Foundation

Lead Sponsor

Citations

1. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/article/S0006-3223(20)30456-X/pdf

One-Year Clinical Outcomes Following Theta Burst ... 05). Conclusions: Veterans with PTSD who received greater cumulative iTBS exposure demonstrated better clinically meaningful outcomes in the year following ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37826976/

Effects of intermittent theta-burst transcranial magnetic ... ITBS, with a shorter treatment duration, can effectively improve the symptoms of PTSD, with no significant difference in effect from that of rTMS.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07192536

Accelerated Neuromodulation for Concurrent Post ... This treatment delivers pulses in very short bursts that mimic natural brain rhythms, and may be effective in treating Post-Traumatic Stress ...

4. medrxiv.org medrxiv.org/content/10.1101/2022.09.11.22279828v1

Effectiveness of theta burst versus high frequency repetitive ... We compared outcomes between these two stimulation protocols used between these dates on symptoms of depression (using changes in the patient ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8453662/

A secondary analysis on effects of theta burst transcranial ... This secondary analysis suggests that iTBS might reduce anger in veterans with PTSD. Future studies focused on more granular level anger outcomes.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123004833

Effects of intermittent theta-burst transcranial magnetic ... ITBS, with a shorter treatment duration, can effectively improve the symptoms of PTSD, with no significant difference in effect from that of rTMS.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9193572/

Transcranial Magnetic Stimulation for Post-traumatic Stress ... Most recently, intermittent theta burst stimulation (iTBS) has been developed which delivers very high frequency stimulation over short periods of time. iTBS is ...

8. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00135-6/pdf

Theta Burst Stimulation Is Not Inferior to High Repetitive transmagnetic stimulation (TMS) has also been applied to reduce symptoms of posttraumatic stress disorder. (PTSD), a distressful and ...

9. cectresourcelibrary.info cectresourcelibrary.info/wp-content/uploads/2021/07/Philip-et-al.-2021-Transcranial-magnetic-stimulation-for-PTSD.pdf

Transcranial Magnetic Stimulation for Posttraumatic Stress ... A recently developed form of TMS, intermittent theta burst stimulation (iTBS), appears noninferior for treating MDD. Because iTBS can be delivered in a fraction ...