TMS for Body Dysmorphic Disorder

(EMPAC-BDD Trial)

Overseen By Research Analyst

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Psychotropics

Disqualifiers: Bipolar, Psychotic, Neurological, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial magnetic stimulation (TMS), a brain stimulation technique, affects visual processing in people with body dysmorphic disorder (BDD). The study aims to determine how different TMS approaches impact brain connections and visual perception, particularly when participants focus on their face. Participants will undergo two types of TMS treatment on separate days, followed by brain scans while viewing images of their faces. Suitable candidates for this trial are adults with significant concerns about their facial appearance who have been medication-free for at least eight weeks. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in understanding and potentially improving treatment for BDD.

Will I have to stop taking my current medications?

Yes, you need to be medication-free for at least 8 weeks before joining the trial, except for certain short-term medications for insomnia or anxiety, which have specific restrictions.

What prior data suggests that transcranial magnetic stimulation (TMS) is safe for use in this study?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe for people. TMS is a noninvasive treatment, meaning it doesn't involve surgery or entering the body. Studies have found that patients with various conditions, such as obsessive-compulsive disorder (OCD) and depression, tolerate it well.

One study found that repetitive TMS (rTMS) helped individuals with body dysmorphic disorder (BDD). Another analysis showed that rTMS is effective for OCD, especially in patients who haven't improved with certain medications. This suggests TMS can be safe and helpful for mental health issues.

While TMS is safe, some people might experience mild side effects, such as headaches or scalp discomfort. These side effects are usually temporary. Overall, current evidence suggests TMS is a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for Body Dysmorphic Disorder because it offers a non-invasive way to potentially treat the condition by directly targeting brain activity. Unlike standard treatments like cognitive-behavioral therapy or medication, which can take weeks or even months to show effectiveness, TMS uses magnetic fields to stimulate nerve cells in the brain, which could lead to quicker symptom relief. The trial explores two variations: iTBS and cTBS, which are different forms of TMS that vary in frequency and intensity, allowing researchers to see which might be more effective or have fewer side effects. This direct brain stimulation approach is a novel method that holds promise for those who haven't responded well to traditional therapies.

What evidence suggests that TMS is effective for body dysmorphic disorder?

Research has shown that transcranial magnetic stimulation (TMS) might help treat body dysmorphic disorder (BDD). This trial will explore different sequences of TMS: one group will receive intermittent Theta Burst Stimulation (iTBS) followed by continuous Theta Burst Stimulation (cTBS), while another group will receive cTBS followed by iTBS. One study found that repetitive TMS (rTMS) reduced symptoms in people with BDD, particularly for those who haven't responded to other treatments. Another study suggested that TMS might improve thinking skills, aiding in managing the obsessive thoughts common in BDD. Although more research is needed, these findings indicate that TMS could assist in how people with BDD process visual information and focus their attention. ^{1 2 6 7 8}

Who Is on the Research Team?

Jamie D Feusner, M.D.

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 with primary concerns about their face or head appearance, who meet the criteria for Body Dysmorphic Disorder (BDD) according to DSM-5. They should score ≥8 on the Dysmorphic Concern Questionnaire and have a BDD-YBOCS score of ≥20. Participants must not be on medications related to BDD or any other condition for at least 8 weeks before joining.

Inclusion Criteria

I am 18-40, worried about my face or head appearance, and haven't taken any related medication for 8 weeks.

Exclusion Criteria

Neurological disorder, Pregnancy, Current major medical disorders affecting cerebral metabolism, Current risk of suicide with a plan and intent, Ferromagnetic metal implantations or devices, Visual acuity worse than 20/35 for each eye

I have been diagnosed with body dysmorphic disorder without severe symptoms.

I have body dysmorphic disorder but no bipolar, psychotic disorders, or current CBT.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

TMS and fMRI Sessions

Participants receive intermittent or continuous TMS followed by an fMRI brain scan while viewing images of their faces.

2 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in brain connectivity and visual processing after TMS and fMRI sessions.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation (TMS)

Trial Overview The study tests two types of TMS: intermittent and continuous theta burst stimulation, focusing on how they affect visual processing in those with BDD symptoms. Each participant will undergo one type of TMS followed by an fMRI scan while viewing images of their faces, then switch the type of TMS the next day.

How Is the Trial Designed?

Group I: iTBS then cTBS Experimental Treatment 2 Interventions

iTBS day 1, cTBS day 2

Group II: cTBS then iTBS Experimental Treatment 2 Interventions

cTBS day 1, iTBS day 2

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

Approved in United States as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Migraine Headache Symptoms

Approved in European Union as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) is a noninvasive technique that shows promise in treating various psychiatric disorders, including depression, anxiety, and schizophrenia, by modulating brain activity.

TMS is generally well-tolerated and can complement other therapies, but more research is needed to understand its cellular mechanisms and long-term effects to optimize treatment protocols for specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current State of Transcranial Magnetic Stimulation and its use in Psychiatry. Zorzo, C., Banqueri, M., Higarza, SG., et al.[2019]

Theta-burst transcranial magnetic stimulation (TBS) is safe and well tolerated in patients with major depression, based on a study involving 33 participants over 10 consecutive days.

The study suggests that TBS may have antidepressant effects, and increasing stimulation parameters does not lead to more side effects, potentially enhancing its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability and preliminary evidence for antidepressant efficacy of theta-burst transcranial magnetic stimulation in patients with major depression. Chistyakov, AV., Rubicsek, O., Kaplan, B., et al.[2019]

The study introduces a novel electronic targeting method for transcranial magnetic stimulation (TMS) using a set of overlapping coils, allowing for faster and more precise stimulation of specific brain areas without the need for physical coil movement.

With just two coils, the device can adjust the stimulation location along a 30-mm line in the cortex, demonstrating a significant advancement in TMS technology that could enhance research and therapeutic applications in brain stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-locus transcranial magnetic stimulation-theory and implementation. Koponen, LM., Nieminen, JO., Ilmoniemi, RJ.[2019]

In a pilot study involving 10 patients with mild cognitive impairment or early dementia, high-frequency rTMS applied to the right inferior frontal gyrus significantly improved attention and psychomotor speed, as measured by the Trail Making Test.

No cognitive improvements were observed with rTMS applied to a control site (vertex), suggesting that targeted stimulation of the right IFG may be an effective intervention for enhancing cognitive functions in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation of the right inferior frontal gyrus may improve attention in early Alzheimer's disease: a pilot study. Eliasova, I., Anderkova, L., Marecek, R., et al.[2022]

Transcranial magnetic stimulation (TMS) is being explored as a promising treatment for psychiatric disorders in children and adolescents, particularly for conditions like depression, ADHD, and autism.

Despite its potential, there is a general lack of knowledge about TMS among child and adolescent psychiatrists, highlighting the need for further education and research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of transcranial magnetic stimulation (TMS) in child and adolescent psychiatry. Croarkin, PE., Wall, CA., Lee, J.[2011]

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that has been approved by the FDA for treating major depression, which affects 350 million people worldwide.

TMS can effectively modulate cortical activity to achieve therapeutic effects in various psychiatric and neurological conditions, with ongoing research into its safety, side effects, and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in transcranial magnetic stimulation (TMS) and its applications in resistant depression. Koutsomitros, T., Evagorou, O., Schuhmann, T., et al.[2022]

In a study of 165 pediatric participants aged 6 to 18, theta-burst TMS (TBS) demonstrated a similar safety profile to single- and paired-pulse TMS (sp/ppTMS), with no severe adverse effects reported.

The overall rate of adverse effects was 10.5% for TBS and 12.4% for sp/ppTMS, with most effects rated as minimal or mild, indicating that TBS is a safe option for further investigation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. Hong, YH., Wu, SW., Pedapati, EV., et al.[2020]

Transcranial magnetic stimulation (TMS) is being explored as a tool to study motor dysfunctions in psychiatric disorders, with preliminary findings suggesting it could help identify markers for these conditions.

Despite challenges like small sample sizes and inconsistent methodologies, TMS shows promise for expanding our understanding of psychiatric disorders beyond motor functions to include cognitive processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation: studying motor neurophysiology of psychiatric disorders. Maeda, F., Pascual-Leone, A.[2018]

Transcranial magnetic stimulation (TMS) was successfully used in a 2-year-old boy with EBV encephalitis, leading to improvements in mutism, ataxia, and other neurological deficits after treatment.

The case suggests that TMS can normalize decreased brain cortex activity, indicating its potential as a therapeutic tool for various neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation. A case report and review of the literature. Anninos, P., Kotini, A., Tamiolakis, D., et al.[2006]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a safe therapeutic alternative for treating eating disorders, with some studies indicating it can reduce cravings and eating behaviors compared to sham treatments.

However, the current research is limited by small sample sizes and inconsistent study designs, highlighting the need for larger, more rigorous trials to better assess the long-term safety and efficacy of rTMS in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in the treatment of eating disorders: A review of safety and efficacy. Rachid, F.[2019]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Transcranial magnetic stimulation (TMS) is an FDA-approved, noninvasive treatment for major depressive disorder (MDD) that is generally well-tolerated and works by inducing a small electric current through a magnetic field.

Due to its success in treating depression, there is growing interest in exploring TMS for other neuropsychiatric conditions in children and adolescents beyond just MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation in Conditions Other than Major Depressive Disorder. Becker, JE., Shultz, EKB., Maley, CT.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36402377/

rTMS Effects in Body Dysmorphic Disorder (BDD) Patients Effects of repetitive transcranial magnetic stimulation (rTMS) in patients with body dysmorphic disorder (BDD)

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178122005984

Interventional Psychiatry for OCD: A Scoping Review Diefenbach et al. A case study of clinical and neuroimaging outcomes following repetitive transcranial magnetic stimulation for hoarding disorder. Am. J ...

3. researchgate.net researchgate.net/publication/365479298_Effects_of_repetitive_transcranial_magnetic_stimulation_rTMS_in_patients_with_body_dysmorphic_disorder_BDD

Effects of repetitive transcranial magnetic stimulation (rTMS ... Deep Transcranial Magnetic Stimulation in combination with symptom provocation: An effective treatment in patients with treatment-resistant Body ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X22000451

Repetitive transcranial magnetic stimulation (r-TMS) and ... This meta-analysis shows that r-TMS is an effective treatment for OCD, but largely for those not resistant to SSRI or failing to respond to only one SSRI trial.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11525394/

TMS for Cognitive Control in Depression: A Review This review found evidence supporting the use of TMS as a treatment for cognitive deficits in patients with MDD. The results are promising.

6. adaa.org adaa.org/finding-help/transcranial-magnetic-stimulation

Transcranial Magnetic Stimulation (TMS) Transcranial magnetic stimulation, known as TMS or rTMS, may be a safe, effective, and noninvasive option for people who have depression that has not improved ...

7. mdpi.com mdpi.com/2076-3425/14/5/483

Neuronavigated Right Orbitofrontal 20 Hz Theta Burst ... The neuronavigated TBS-20 Hz sequential stimulation of RDLPFC and LDLPFC, followed by ROFC, significantly reduced OCD, MDD, and GAD/PD symptoms.

8. psychiatrist.com psychiatrist.com/jcp/theta-burst-repetitive-transcranial-magnetic-stimulation/

Theta-Burst Repetitive Transcranial Magnetic Stimulation ... The results suggest that TBS could be a potential treatment for treatment-resistant obsessive-compulsive disorder and major depressive disorder.