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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms: Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.

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 data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for Schizophrenia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can be effective in treating negative symptoms of schizophrenia, especially in patients who do not respond well to medication. Studies have found that rTMS, when used alongside other treatments, can help improve symptoms in these patients. ^{1 2 3 4 5}

How is transcranial magnetic stimulation (rTMS) different from other treatments for schizophrenia?

Transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, which is different from standard antipsychotic medications that work by altering chemical levels in the brain. It is particularly being explored for patients who do not respond well to medications, focusing on reducing negative symptoms and auditory hallucinations in schizophrenia. ^{2 5 6 7 8}

Eligibility Criteria

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 am between 18 and 40 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. China pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of high dose transcranial magnetic stimulation in schizophrenia with refractory negative symptoms: a randomized controlled study]. [2018]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Augmentation therapy of resistant schizophrenia with rhythmic transcranial magnetic stimulation]. [2023]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of non-invasive brain stimulation on the symptom dimensions of schizophrenia: A meta-analysis of randomized controlled trials. [2022]

6. England pubmed.ncbi.nlm.nih.gov

High frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex in schizophrenic patients. [2022]

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

Investigational and Therapeutic Applications of Transcranial Magnetic Stimulation in Schizophrenia. [2022]

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

A review of repetitive transcranial magnetic stimulation use in the treatment of schizophrenia. [2022]