TMS for Depression

(T5 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Joseph J Taylor, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Brigham and Women's Hospital

Must not be taking: Ketamine, Esketamine, ECT, others

Disqualifiers: Pregnancy, Autism, Neurological illness, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.

Will I have to stop taking my current medications?

Participants must have a stable psychiatric medication regimen or be medication-free for 4 weeks before starting the trial and must continue this regimen throughout the study until two weeks after treatment.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation (TMS) for depression?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally well tolerated and more effective than a placebo treatment for depression, with some studies indicating improved outcomes over time. It has been found to be effective in both short-term and some long-term cases, especially in patients who have not responded to other treatments. ^{1 2 3 4 5}

Is Transcranial Magnetic Stimulation (TMS) safe for humans?

TMS, also known as rTMS, is generally considered safe for humans when used within recommended guidelines. Common side effects are minor, like headaches, but there is a low risk of seizures and mood changes, which can be managed by screening for risk factors. ^{6 7 8 9 10}

How is the treatment rTMS for depression different from other treatments?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is different from medications that work chemically. It is a non-invasive procedure, meaning it doesn't require surgery or medication, and is often used when other treatments haven't worked. ^{3 5 11 12 13}

Eligibility Criteria

This trial is for adults aged 18-65 with depression and another psychiatric disorder like anxiety, OCD, or PTSD. Participants must speak English well enough for consent and treatment, have a stable medication regimen or be medication-free for four weeks prior to the study, and show moderate to severe treatment resistance.

Inclusion Criteria

I have been diagnosed with PTSD.

My condition is hard to treat and has not responded well to treatments.

I am between 18 and 65 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated intermittent theta burst stimulation (iTBS) targeting the posterior parietal cortex, with 10 sessions per day for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

12 months

6 visits (in-person)

Treatment Details

Interventions

• Transcranial Magnetic Stimulation (Other)

Trial Overview The trial tests accelerated intermittent theta burst stimulation using transcranial magnetic stimulation (TMS) on the posterior parietal cortex. It aims to assess safety, symptom improvement in depression and other disorders, as well as changes in brain function.

Participant Groups

Group I: Open-label aiTBS to posterior parietal cortex Experimental Treatment 1 Intervention

10 iTBS treatment sessions per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total). In the unlikely event that a participant is late for an hourly treatment, then the treatment will be delayed accordingly. The minimum gap between treatments will be 25 minutes. Each iTBS treatment will consist of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation will be delivered at 90% resting motor threshold (rMT), adjusted for depth of the identified functional connectivity target.

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

🇨🇦 Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Hospital Boston, MA

Who Is Running the Clinical Trial?

Brigham and Women's Hospital Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved? A systematic review and meta-analysis comparing the recent vs. the earlier rTMS studies. [2018] To investigate whether the recent repetitive transcranial magnetic stimulation (rTMS) studies on depression using new parameters of stimulation have shown improved clinical results.

2. United States pubmed.ncbi.nlm.nih.gov

Three and six-month outcome following courses of either ECT or rTMS in a population of severely depressed individuals--preliminary report. [2019] Recent studies have strengthened the claim that repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depression. The longitudinal outcome of TMS-treated patients, however, has not been described. We report on the 3- and 6-month outcomes of a group of patients treated with either electroconvulsive therapy (ECT) (n = 20) or (rTMS) (n = 21).

3. England pubmed.ncbi.nlm.nih.gov

Adjunctive fast repetitive transcranial magnetic stimulation in depression. [2018] The place of repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression remains unclear. In this sham-controlled study we determined the efficacy and acceptability offast, left frontal rTMS given three times a week over 4-6 weeks to 29 patients with depression (79% treatment-resistant). The procedure was generally well tolerated and more effective than sham treatment (55 v.77% responding, P

4. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression. [2022] Effectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.

5. England pubmed.ncbi.nlm.nih.gov

Naturalistic study of the use of transcranial magnetic stimulation in the treatment of depressive relapse. [2022] The efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression has been assessed in a number of acute treatment trials during the last 10 years. Little is known about the long-term impact of the treatment on the disorder and its effectiveness when applied for repeated relapses of depression over time.

6. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019] Repetitive transcranial magnetic stimulation (rTMS) is increasingly being utilised as a treatment option for depression, and with this comes a need for a practical review of safety issues intended for clinicians. This article provides an overview of the current literature regarding safety issues with rTMS for depression, and provides recommendations for clinical practice.

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Treatment-Resistant Depression Entering Remission Following a Seizure during the Course of Repetitive Transcranial Magnetic Stimulation. [2020] Major depressive disorder is often resistant to antidepressant treatment. Repetitive transcranial magnetic stimulation (rTMS) has been used in treatment-resistant depression (TRD). Known adverse events of rTMS include transient headache, local pain, syncope, seizure induction, and hypomania induction. This report outlines a patient with TRD who unexpectedly improved following a seizure during the course of rTMS, which has never been reported.

8. United States pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019] The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported.

9. England pubmed.ncbi.nlm.nih.gov

Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021] In the last decade, repetitive transcranial magnetic stimulation (rTMS) has been introduced as a non-invasive neuromodulation therapy for depression. Little is known, however, about (serious) adverse events (AE) of rTMS in older adults with a depression. In this article, we want to study what is known about (serious) AE of rTMS in older adults (>60 years) with late-life depression (LLD).

10. England pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. [2021] There is growing interest worldwide in rTMS as a clinical treatment for depression. Apart from efficacy, its safety as a clinical treatment must be considered before its widespread use can be advocated. All published, sham-controlled rTMS depression trials were reviewed for reported side-effects and outcomes of formal neuropsychological testing. In addition, all reports of seizures occurring with rTMS were reviewed. Other safety concerns (effects on hearing; headache, pain, induced currents in electrical circuits, histotoxicity, electromagnetic field exposure, psychiatric complications, safety in pregnancy) are discussed. Common side-effects were of a minor nature, e.g. headache. There was a low incidence of accidental seizures and induced hypomania, both of which were associated with identified risk factors for which subjects should be screened. Long-term effects of repeated rTMS sessions are as yet unknown. When given within recommended guidelines, the overall safety profile of rTMS is good, and supports its further development as a clinical treatment.

11. Netherlands pubmed.ncbi.nlm.nih.gov

An update on the clinical use of repetitive transcranial magnetic stimulation in the treatment of depression. [2021] Repetitive transcranial magnetic stimulation (rTMS) is an increasingly used treatment for patients with depression. The use of rTMS in depression is supported by over 20 years of clinical trials. There has been a significant increase in knowledge around the use of rTMS in recent years.

12. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of mood disorder: a review and comparison with electroconvulsive therapy. [2017] To review repetitive transcranial magnetic stimulation (rTMS) as a mode of therapy for depression.

13. United States pubmed.ncbi.nlm.nih.gov

A practical guide to the use of repetitive transcranial magnetic stimulation in the treatment of depression. [2022] Repetitive transcranial magnetic stimulation (rTMS) is currently emerging as a new treatment for patients with mood disorders. Research into the use of rTMS for the treatment of patients with depression has been conducted now for a period of greater than 15 years and a considerable body of knowledge has accumulated informing its use.