Accelerated TMS for Schizophrenia

(ATP Trial)

Overseen By Adam Beermann, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Epilepsy, Pregnancy, Metal implants, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a faster schedule of Transcranial Magnetic Stimulation (TMS) to determine its effectiveness in treating symptoms of schizophrenia, which affects thinking and perception. It uses repetitive TMS, a non-invasive method where magnetic fields stimulate nerve cells in the brain. Individuals with schizophrenia, or those at high risk and in stable treatment without recent medication changes, may be suitable candidates. The trial aims to assess the method's effectiveness and patient tolerance. As a Phase 1 and Phase 2 trial, the research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in schizophrenia treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, your medications will be reviewed by the study's principal investigator to decide if you can participate, based on your medical history and current treatment.

What prior data suggests that this method is safe for treating schizophrenia?

Studies have shown that repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe and well-tolerated for people with schizophrenia. Research indicates that individuals with schizophrenia do not face a higher risk of serious side effects, such as seizures, when using rTMS. In fact, side effects related to rTMS are usually mild and occurred in about 16.7% of participants. While a seizure is the most serious possible side effect, it remains rare. Overall, rTMS appears to be a safe option for those considering this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for schizophrenia, like antipsychotic medications, work by altering neurotransmitter levels in the brain to manage symptoms. But repetitive Transcranial Magnetic Stimulation (rTMS) offers a different approach. It uses magnetic fields to stimulate nerve cells, which researchers believe can lead to quicker and potentially more effective relief, especially when applied in an accelerated protocol. This method targets the brain directly and non-invasively, offering hope for faster symptom improvement without the side effects often associated with medication. Researchers are excited about rTMS because it could revolutionize how we manage schizophrenia, making treatment more accessible and tolerable for patients.

What evidence suggests that repetitive Transcranial Magnetic Stimulation (rTMS) might be an effective treatment for schizophrenia?

Research shows that repetitive Transcranial Magnetic Stimulation (rTMS), which participants in this trial will receive, can help treat symptoms of schizophrenia. Studies have found that rTMS reduces negative symptoms, like a lack of emotion or motivation, and works better than placebo treatments. It also improves thinking skills, such as memory and language. Imaging-guided rTMS safely reduces auditory hallucinations (hearing voices) in people with schizophrenia. Overall, rTMS appears promising in improving both mental and emotional symptoms of this condition. ^{4 5 6 7 8}

Who Is on the Research Team?

Roscoe O Brady, MD, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a diagnosis of schizophrenia, schizoaffective disorder, or at high risk for psychosis. Participants must be stable outpatients, fluent in English, and capable of completing study procedures without recent hospitalizations or medication changes.

Inclusion Criteria

I am able to complete all study-related procedures.

Must be able to read, speak, and understand English

I have been diagnosed with schizophrenia or schizoaffective disorder, or I am at high risk for developing a psychotic disorder.

Exclusion Criteria

I don't have conditions that increase risks from rTMS or MRI.

I have had a head injury that caused me to lose consciousness for a long time or left me with lasting neurological issues.

I have had fainting spells that might be seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated TMS sessions multiple times per day over 5 days

1 week

Multiple sessions per day

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Assessments at 1 week, 3 weeks, and 24 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The trial tests the safety and effectiveness of an accelerated schedule of repetitive Transcranial Magnetic Stimulation (rTMS) to treat symptoms associated with psychotic disorders like schizophrenia.

How Is the Trial Designed?

Group I: repetitive Transcranial Magnetic Stimulation (rTMS) Experimental Treatment 1 Intervention

repetitive Transcranial Magnetic Stimulation (rTMS) in a iTBS pattern to the cerebellum at 100% of resting motor threshold

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38232567/

An umbrella review of systematic reviews and meta-analyses

Most reviews indicate that rTMS has an effect on negative symptoms, executive function, working memory, and language function in patients with schizophrenia.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165178124000155

Efficacy of repetitive transcranial magnetic stimulation ...

Most reviews indicate that rTMS has an effect on negative symptoms, executive function, working memory, and language function in patients with schizophrenia.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37788803/

Effectiveness of Repetitive Transcranial Magnetic ...

rTMS was superior to sham in the reduction of negative symptoms of schizophrenia (mean difference [MD]: 0.47; 95% CI, 0.23-0.7; P < .0001).

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2825941

Repetitive Transcranial Magnetic Stimulation for Auditory ...

The findings of this randomized clinical trial suggest that imaging-navigated rTMS may effectively and safely alleviate AVH in patients with schizophrenia.

5.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1496562/full

Effects of repetitive transcranial magnetic stimulation on ...

In summary, this study demonstrates that rTMS targeting the DLPFC can significantly improve inhibitory control in individuals with schizophrenia ...

6.

academic.oup.com

academic.oup.com/schizophreniabulletin/article/51/2/392/7758322

Safety of rTMS for Schizophrenia: A Systematic Review and ...

rTMS is safe and well tolerated for people with schizophrenia. Individuals with schizophrenia are not at increased risk for adverse effects, including seizure.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3656498/

Safety and tolerability of repetitive transcranial magnetic ...

Adverse events associated with rTMS were generally mild and occurred in 16.7% of subjects. Seizure was the most serious adverse event, and occurred in three ...

8.

psychiatrist.com

psychiatrist.com/pcc/effectiveness-repetitive-transcranial-magnetic-stimulation-depression-schizophrenia-obsessive-compulsive-disorder-umbrella-meta-analysis/

Effectiveness of Repetitive Transcranial Magnetic ...

To analyze the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, schizophrenia, and obsessive- ...