TMS for Schizophrenia
(MESSI Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Must be taking: Antipsychotics
Disqualifiers: Neurological disorder, Seizures, others
Approved in 2 jurisdictions
Trial Summary
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.
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.
12345Is 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.
16789How 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.
1491011Eligibility Criteria
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.
+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.
+4 more
Trial Timeline
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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
UCSFSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
[Effectiveness and safety of high dose transcranial magnetic stimulation in schizophrenia with refractory negative symptoms: a randomized controlled study]. [2018]To evaluate the efficacy and safety of high dose transcranial magnetic stimulation (rTMS) in patients with schizophrenia with refractory negative symptoms.
[Augmentation therapy of resistant schizophrenia with rhythmic transcranial magnetic stimulation]. [2023]To identify the clinical efficacy of rhythmic transcranial magnetic stimulation (rTMS) in resistant schizophrenia.
Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study. [2011]We evaluated the efficacy of bimodal repetitive transcranial magnetic stimulation (rTMS) in treating pharmacologically non-responsive patients with schizophrenia.
[Effects of repetitive transcranial magnetic stimulation with different paradigms on the cognitive function and psychotic symptoms of schizophrenia patients]. [2017]To evaluate the effect of different paradigms of repetitive transcranial magnetic stimulation (rTMS) on the treatment of schizophrenia through assessing cognitive function and psychotic symptoms.
Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study. [2021]Current meta-analysis revealed small, but significant effects of repetitive transcranial magnetic stimulation (rTMS) on negative symptoms in patients with schizophrenia. There is a need for further controlled, multicenter trials to assess the clinical efficacy of rTMS on negative symptoms in schizophrenia in a larger sample of patients. The objective of this multicenter, randomized, sham-controlled, rater- and patient-blind clinical trial is to investigate the efficacy of 3-week 10-Hz high frequency rTMS add on to antipsychotic therapy, 15 sessions per 3 weeks, 1,000 stimuli per session, stimulation intensity 110% of the individual motor threshold) of the left dorsolateral prefrontal cortex for treating negative symptoms in schizophrenia, and to evaluate the effect during a 12 weeks of follow-up. The primary efficacy endpoint is a reduction of negative symptoms as assessed by the negative sum score of the positive and negative symptom score (PANSS). A sample size of 63 in each group will have 80% power to detect an effect size of 0.50. Data analysis will be based on the intention to treat population. The study will be conducted at three university hospitals in Germany. This study will provide information about the efficacy of rTMS in the treatment of negative symptoms. In addition to psychopathology, other outcome measures such as neurocognition, social functioning, quality of life and neurobiological parameters will be assessed to investigate basic mechanisms of rTMS in schizophrenia. Main limitations of the trial are the potential influence of antipsychotic dosage changes and the difficulty to ensure adequate blinding.
Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. [2020]Negative symptoms are one of the most difficult areas in the treatment of schizophrenia because antipsychotics are often less effective towards them. Repetitive transcranial magnetic stimulation (rTMS) is a new technique for cerebral cortex stimulation and is believed to be a safe and promising method for the treatment of mental disorders. As the clinical research and new treatment models have increased in recent years, the efficacy towards negative symptoms and safety evaluation of rTMS treatment should also be updated.
Delayed effect of repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia: Findings from a randomized controlled trial. [2018]Evidence is inconsistent regarding the effect of repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. In this study, 47 patients were randomized to receive either active rTMS over left dorsolateral prefrontal cortex (n=25) or sham stimulation (n=22). Negative symptoms were assessed with the Scale for the Assessment of Negative Symptoms (SANS) at baseline, 4 weeks and 8 weeks. At 4 weeks, there was no difference in SANS scores between 2 groups. By 8 weeks, patients with active rTMS had significantly reduced SANS score than controls. Our findings suggest a delayed effect of rTMS on negative symptoms.
Deep transcranial magnetic stimulation add-on for treatment of negative symptoms and cognitive deficits of schizophrenia: a feasibility study. [2016]Treatment for negative symptoms and cognitive deficits, core elements of schizophrenia, remains inadequate. Stimulation of the prefrontal cortex via transcranial magnetic stimulation (TMS) yields only moderate results, possibly due to limited stimulation depth. Deep-TMS enables deeper and wider stimulation than before. This preliminary study is the first to examine deep-TMS as a possible add-on treatment for negative symptoms and cognitive deficits of schizophrenia. The effect of 20 daily deep-TMS sessions (20 Hz, 120% motor threshold) over the prefrontal cortex of 15 patients indicated improvement in cognition and negative symptoms that was maintained at 2-wk post-treatment follow-up.
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]The potential effect of repetitive transcranial magnetic stimulation (rTMS) on core positive and negative symptoms in schizophrenia has not yet been clearly established. The aim of this study was to examine the efficacy of adjuvant 10 Hz, suprathreshold left prefrontal rTMS in negative symptoms of schizophrenia in a double-blind sham-controlled design. Additionally, our study also investigated the suitability of applying the same stimulus condition on positive symptoms. Ten right-handed schizophrenia patients received sham or active 10 Hz suprathreshold rTMS to the left dorsolateral prefrontal cortex with psychopathology, depression and global improvement ratings before and after rTMS sessions. Compared to sham, active rTMS significantly improved negative symptoms, irrespective of change in depressive symptoms.
Different Modalities of Transcranial Magnetic Stimulation to Manage Schizophrenia. [2022]Objective: To analyze all current literature related to different transcranial magnetic stimulation (TMS) modalities in the management of schizophrenia symptoms and compare the main controversies in the outcome measures.
Investigational and Therapeutic Applications of Transcranial Magnetic Stimulation in Schizophrenia. [2022]This current review summarizes the investigational and therapeutic applications of transcranial magnetic stimulation (TMS) in schizophrenia.