Accelerated TMS for Schizophrenia

(ATP Trial)

RO
AB
Overseen ByAdam Beermann, MA
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.45678

Who Is on the Research Team?

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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.
See 1 more

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.
See 10 more

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?
1Treatment groups
Experimental Treatment
Group I: repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment1 Intervention

Find a Clinic Near You

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.govpubmed.ncbi.nlm.nih.gov/38232567/
An umbrella review of systematic reviews and meta-analysesMost reviews indicate that rTMS has an effect on negative symptoms, executive function, working memory, and language function in patients with schizophrenia.
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.govpubmed.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).
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.
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 ...
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.
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 ...
Effectiveness of Repetitive Transcranial Magnetic ...To analyze the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, schizophrenia, and obsessive- ...
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