160 Participants Needed

TMS for Schizophrenia

(MESSI Trial)

YJ
KS
YJ
Overseen ByYingxin Jia
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
Must be taking: Antipsychotics
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized controlled trial in healthy controls (HC) and patients with schizophrenia (SZ) aims to examine 1) the underlying cognitive and neural cause of self-agency deficits in SZ; 2) the responsiveness to a novel navigated repetitive transcranial magnetic stimulation (nrTMS) target in the medial/superior prefrontal cortex (mPFC); and 3) how modulation of mPFC activity impacts the larger self-agency network to mediate changes in self-agency judgments. Our overall hypothesis is that increased mPFC excitability by active high-frequency nrTMS in HC and SZ will induce behavioral improvements in self-agency and neural changes in the larger self-agency network that will generalize to improvements in overall cognition, symptoms and daily functioning, and will likely lead to the development of new effective neuromodulation therapies in patients with schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires schizophrenia participants to be on a stable dose of antipsychotic medication for at least 4 weeks. It seems you can continue your current medications if they meet this stability requirement.

Is transcranial magnetic stimulation (TMS) safe for humans?

Research suggests that repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for treating mental disorders, including schizophrenia, with no major safety concerns reported in studies.12345

How is the treatment nrTMS different from other treatments for schizophrenia?

Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, which can help improve symptoms of schizophrenia, especially negative symptoms like lack of motivation or emotion. Unlike medications, it is a non-invasive procedure and does not involve taking drugs.45678

What data supports the effectiveness of the treatment Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) for schizophrenia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can have small but significant effects on reducing negative symptoms in schizophrenia. Studies suggest that rTMS, when added to antipsychotic therapy, may improve symptoms like lack of motivation and social withdrawal.4791011

Who Is on the Research Team?

KS

Karuna Subramaniam, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with schizophrenia who are clinically stable on a low to moderate dose of antipsychotic medication, without neurological disorders or substance use issues. They must be in good physical health and able to undergo MRI scans. Pregnant individuals, those with implanted metal/electronic devices, scalp wounds/infections, ongoing seizures, or severe claustrophobia cannot participate.

Inclusion Criteria

You have undergone an MRI scan and the results meet the requirements for the study.
You are not currently struggling with addiction to alcohol or drugs.
I am in good overall health.
See 4 more

Exclusion Criteria

I have wounds or infections on my scalp.
You are afraid of being in small spaces and cannot undergo an MRI.
You have metal implants or electronic devices inside your body.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Assessment

Participants complete baseline assessments including cognitive, clinical, and daily functioning assessments, structural MRI, and MEGI scans

1 week
Multiple visits (in-person)

Treatment

Participants receive nrTMS targeting either the medial prefrontal cortex or a control posterior parietal site

1 week
Multiple visits (in-person)

Follow-up

Participants are monitored for changes in neural activity, cognition, clinical symptoms, and daily functioning after TMS

4 weeks
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS)
Trial Overview The study tests whether high-frequency transcranial magnetic stimulation (TMS) targeting the medial prefrontal cortex can improve self-agency judgments in people with schizophrenia. It will also assess cognitive improvements and daily functioning as well as potential changes within the brain's self-agency network.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Medial/Superior Prefrontal TMSActive Control1 Intervention
10 Hz High frequency TMS applied to the mPFC
Group II: Posterior Parietal TMSPlacebo Group1 Intervention
10 Hz high frequency TMS applied to the posterior parietal cortex

Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as rTMS for:
  • Major Depressive Disorder
  • Negative symptoms in schizophrenia
🇺🇸
Approved in United States as rTMS for:
  • Major Depressive Disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

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.
[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.
[Augmentation therapy of resistant schizophrenia with rhythmic transcranial magnetic stimulation].Pomytkin, AN., Tikhonov, DV., Kaleda, VG.[2023]
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.
Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study.Oh, SY., Kim, YK.[2011]

Citations

[Effectiveness and safety of high dose transcranial magnetic stimulation in schizophrenia with refractory negative symptoms: a randomized controlled study]. [2018]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Augmentation therapy of resistant schizophrenia with rhythmic transcranial magnetic stimulation]. [2023]
Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study. [2011]
[Effects of repetitive transcranial magnetic stimulation with different paradigms on the cognitive function and psychotic symptoms of schizophrenia patients]. [2017]
Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study. [2021]
Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. [2020]
Delayed effect of repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia: Findings from a randomized controlled trial. [2018]
Deep transcranial magnetic stimulation add-on for treatment of negative symptoms and cognitive deficits of schizophrenia: a feasibility study. [2016]
Efficacy of adjuvant high frequency repetitive transcranial magnetic stimulation on negative and positive symptoms of schizophrenia: preliminary results of a double-blind sham-controlled study. [2007]
10.United Statespubmed.ncbi.nlm.nih.gov
Different Modalities of Transcranial Magnetic Stimulation to Manage Schizophrenia. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Investigational and Therapeutic Applications of Transcranial Magnetic Stimulation in Schizophrenia. [2022]
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