Transcranial Magnetic Stimulation for Schizophrenia

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Must be taking: Antipsychotics

Disqualifiers: Substance abuse, Seizure history, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether transcranial magnetic stimulation (TMS), a non-invasive treatment using magnetic fields to stimulate the brain, can improve brain and cognitive functions in people with schizophrenia. Participants will receive either the active TMS treatment or a sham (placebo) version, alongside their usual care. This approach helps researchers determine the effectiveness of the real treatment. Suitable candidates have been diagnosed with schizophrenia and have not received TMS in the last three months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that participants will continue with their Standard of Care (SOC), which usually means continuing with your current treatment plan.

What prior data suggests that Transcranial Magnetic Stimulation is safe for schizophrenia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is safe and well-tolerated for people with schizophrenia. Studies have found that individuals with schizophrenia do not face a higher risk of serious side effects like seizures. Most patients report that rTMS treatments are comfortable, and no serious side effects have been reported. Overall, the evidence supports rTMS as a safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, offering a non-invasive approach to treating schizophrenia. Unlike traditional treatments like antipsychotic medications that primarily target chemical imbalances, TMS focuses on electrical activity in specific brain regions associated with schizophrenia symptoms. Researchers are excited about TMS because it could provide a new option for patients who don't respond well to medication, with the potential for fewer side effects. Additionally, TMS can be precisely targeted, allowing for more personalized treatment plans.

What evidence suggests that Transcranial Magnetic Stimulation might be an effective treatment for schizophrenia?

Research has shown that transcranial magnetic stimulation (TMS) could help treat schizophrenia, particularly its negative symptoms. In this trial, participants will receive either TMS or a sham treatment. One study found that repetitive TMS (rTMS) was more effective than a fake treatment in reducing these symptoms. Another review noted improvements in thinking skills, memory, and language abilities. Additionally, imaging-guided rTMS safely reduced auditory hallucinations in patients. However, some studies report only limited benefits, indicating that more research is needed. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-40 with a diagnosis of schizophrenia spectrum disorders. It's not suitable for those with cerebellar disorders, recent TMS or ECT treatments, MRI contraindications, active medical conditions affecting cognition, substance abuse within six months, seizure history, or other major psychiatric or neurodegenerative diagnoses.

Inclusion Criteria

I have been diagnosed with a schizophrenia spectrum disorder.

I understand and can agree to the study's procedures and risks.

Exclusion Criteria

Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders

Pregnancy as indicated by self-report

Substance dependence or abuse in the past six months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment five days per week for four consecutive weeks

4 weeks

20 visits (in-person)

Assessment

Functional MRI scans, clinical assessments, and cognitive tests are performed

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview

The study tests the impact of Transcranial Magnetic Stimulation (rTMS) on brain and cognitive functions in schizophrenia patients over four weeks. Participants will either receive real rTMS plus standard care or sham rTMS (a placebo-like procedure) plus standard care to compare effects.

How Is the Trial Designed?

Group I: TMS Experimental Treatment 1 Intervention

Group II: Sham Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

High dose transcranial magnetic stimulation (rTMS) at 10 Hz significantly reduced negative symptoms in schizophrenia patients, particularly blunted affect, emotional withdrawal, and passive/apathetic social withdrawal, with an effective rate of 43.75% compared to 11.43% in the control group.

While rTMS was found to be effective, it was associated with a higher incidence of headaches (37.50% in the study group) compared to the control group, indicating a need for monitoring side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of high dose transcranial magnetic stimulation in schizophrenia with refractory negative symptoms: a randomized controlled study]. Gan, J., Duan, H., Chen, Z., et al.[2018]

Rhythmic transcranial magnetic stimulation (rTMS) showed significant efficacy in reducing symptoms of resistant schizophrenia, particularly in patients with depressive, hallucinatory, and negative symptoms, with reductions in PANSS scores of 24.4%, 8.3%, and 11.7% respectively after 15 sessions over 3 weeks.

However, rTMS was not effective for patients with delusional symptoms, leading to a worsening of their condition, indicating that treatment must be tailored to the specific symptoms of schizophrenia for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Augmentation therapy of resistant schizophrenia with rhythmic transcranial magnetic stimulation]. Pomytkin, AN., Tikhonov, DV., Kaleda, VG.[2023]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a treatment for patients with schizophrenia who do not respond to standard antipsychotic medications, particularly in reducing persistent auditory hallucinations.

Preliminary evidence suggests rTMS may also help alleviate negative symptoms of schizophrenia and improve cognitive function, but more extensive multisite studies are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of repetitive transcranial magnetic stimulation use in the treatment of schizophrenia. Fitzgerald, PB., Daskalakis, ZJ.[2022]

In a study involving 51 schizophrenic subjects, 20 sessions of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) significantly reduced negative symptoms of schizophrenia compared to placebo and low-frequency (1 Hz) treatments.

The results suggest that rTMS could be a promising noninvasive add-on treatment for managing negative symptoms in schizophrenia, although secondary cognitive measures did not show significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) as an augmentation treatment for the negative symptoms of schizophrenia: a 4-week randomized placebo controlled study. Schneider, AL., Schneider, TL., Stark, H.[2022]

Transcranial direct current stimulation (tDCS) showed significant improvement in negative symptoms of schizophrenia, with a moderate effect size (Hedge's g = -0.63), while also improving all symptom dimensions compared to sham treatment.

Repetitive transcranial magnetic stimulation (rTMS) effectively reduced hallucinations and negative symptoms, but was linked to a slight worsening of positive symptoms, highlighting the need for careful consideration of stimulation parameters and patient characteristics in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of non-invasive brain stimulation on the symptom dimensions of schizophrenia: A meta-analysis of randomized controlled trials. Kennedy, NI., Lee, WH., Frangou, S.[2022]

Bimodal repetitive transcranial magnetic stimulation (rTMS) significantly reduced symptoms of schizophrenia in 10 patients who were unresponsive to medication, with improvements noted in all subscales of the Positive and Negative Syndrome Scale (PANSS) by Day 29.

The treatment also showed potential benefits for short-term auditory verbal memory, as indicated by significant increases in neurocognitive test scores after the rTMS sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study. Oh, SY., Kim, YK.[2011]

Transcranial magnetic stimulation (TMS) has shown promise in treating persistent auditory hallucinations in schizophrenia, particularly with 1-Hz TMS applied to the left temporoparietal cortex, indicating its potential as a short-term therapeutic option.

High-frequency TMS targeting the left prefrontal cortex may help improve negative and cognitive symptoms of schizophrenia, although the effects are inconsistent and generally small, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational and Therapeutic Applications of Transcranial Magnetic Stimulation in Schizophrenia. Mehta, UM., Naik, SS., Thanki, MV., et al.[2022]

In a study involving 12 schizophrenia patients, repetitive transcranial magnetic stimulation (rTMS) significantly reduced psychiatric symptoms as measured by the Brief Psychiatric Rating Scale after 2 weeks of active treatment compared to sham stimulation.

While rTMS showed efficacy in improving overall psychiatric symptoms, it did not significantly affect depressive or anxiety symptoms, suggesting its potential as a non-pharmacological treatment specifically for psychotic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex in schizophrenic patients. Rollnik, JD., Huber, TJ., Mogk, H., et al.[2022]

Citations

1.

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).

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.

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.

4.

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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20633367/

A study of the effectiveness of bilateral transcranial ...

Conclusions: No substantial benefit of high-frequency bilateral rTMS was seen in the treatment of the negative symptoms of schizophrenia. Further research is ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39278637

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

Conclusions: rTMS is safe and well tolerated for people with schizophrenia. Individuals with schizophrenia are not at increased risk for adverse ...

7.

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.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00564096

Transcranial Magnetic Stimulation (TMS) in Schizophrenia

Generally, the TMS treatment was reported to be well tolerated. No serious adverse effects were reported by any of the patients. There is no evidence that rTMS ...