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

Trial Summary

What is the purpose of this trial?

This trial tests the effects of transcranial magnetic stimulation (TMS) on visual processing in adults with body dysmorphic disorder (BDD). TMS uses magnetic fields to stimulate specific brain areas, aiming to improve how these individuals perceive their appearance. The study hopes to find new ways to help people with BDD by enhancing their brain's visual processing capabilities. TMS is a noninvasive technique that has been used for diagnostic and therapeutic purposes in various neuropsychiatric disorders, including depression and bipolar disorder.

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 data supports the effectiveness of the treatment TMS for Body Dysmorphic Disorder?

TMS is a non-invasive treatment that has been successful in treating major depressive disorder and is being explored for other psychiatric conditions, suggesting potential benefits for Body Dysmorphic Disorder as well. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

Research shows that various forms of transcranial magnetic stimulation (TMS), including repetitive TMS (rTMS) and theta-burst stimulation (TBS), are generally safe for humans. Studies have found that these treatments are well-tolerated in conditions like obesity, eating disorders, and depression, with most trials reporting a reassuring safety profile. ^{6 7 8 9 10}

How is TMS treatment different from other treatments for Body Dysmorphic Disorder?

TMS (Transcranial Magnetic Stimulation) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, unlike traditional treatments that may involve medication or talk therapy. It is particularly novel for Body Dysmorphic Disorder as there are no standard treatments specifically approved for this condition. ^{1 5 11 12 13}

Research Team

Jamie D Feusner, M.D.

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

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, have intense concerns about my face or head's appearance, and haven't taken any medication for it in the last 8 weeks.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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) 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]

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]

References

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

Multi-locus transcranial magnetic stimulation-theory and implementation. [2019]

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

Transcranial Magnetic Stimulation in Conditions Other than Major Depressive Disorder. [2019]

3. Netherlands 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. [2022]

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

Applications of transcranial magnetic stimulation (TMS) in child and adolescent psychiatry. [2011]

5. Spain pubmed.ncbi.nlm.nih.gov

Current State of Transcranial Magnetic Stimulation and its use in Psychiatry. [2019]

6. Switzerland 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability and preliminary evidence for antidepressant efficacy of theta-burst transcranial magnetic stimulation in patients with major depression. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

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

9. Ireland 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. [2022]

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

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation: studying motor neurophysiology of psychiatric disorders. [2018]

12. Greece pubmed.ncbi.nlm.nih.gov

Advances in transcranial magnetic stimulation (TMS) and its applications in resistant depression. [2022]

13. Italy pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation. A case report and review of the literature. [2006]