Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Must not be taking: Clozapine
Disqualifiers: Seizures, Substance abuse, Major illnesses, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking more than 400 mg of clozapine per day.
What data supports the effectiveness of the treatment rTMS for schizophrenia?
Some studies suggest that repetitive transcranial magnetic stimulation (rTMS) can improve negative symptoms in schizophrenia, especially when other treatments haven't worked. However, results are mixed, and not all studies show significant benefits.
12345Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans and has been used in various studies for mental disorders, including schizophrenia. Research suggests it is a promising method with a good safety profile when used as a treatment.
26789How does the treatment rTMS differ from other treatments for schizophrenia?
Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, like the dorsolateral prefrontal cortex, which is linked to schizophrenia symptoms. Unlike traditional medications, rTMS is non-invasive and can target negative symptoms of schizophrenia, although its effects may be delayed and vary among individuals.
457810Eligibility Criteria
This trial is for men and women aged 18-65 with schizophrenia-spectrum disorder who can consent to participate. Excluded are those with major medical conditions affecting the brain, high clozapine doses, failed TMS screening, significant head injury or surgery, pregnancy without contraception, metal implants near the head, seizure history, or recent substance abuse.Inclusion Criteria
Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10
I am between 18 and 65 years old.
I am 18 or older and can sign a consent form.
Exclusion Criteria
I have a history of seizures.
I do not have any major illnesses affecting my brain function.
Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive sham and active rTMS in separate sessions to assess SSD-related biomarkers
2 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after rTMS sessions
4 weeks
Participant Groups
The study tests active versus sham (fake) repetitive transcranial magnetic stimulation (rTMS) on patients with schizophrenia. It aims to see how rTMS affects certain biomarkers related to the disorder by comparing results before and after treatment in separate sessions.
2Treatment groups
Experimental Treatment
Group I: Sham rTMS first and active rTMS secondExperimental Treatment1 Intervention
Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit.
Group II: Active rTMS first and sham rTMS secondExperimental Treatment1 Intervention
Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit.
rTMS is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
- Migraines
- Smoking cessation
๐ช๐บ Approved in European Union as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland, BaltimoreBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
References
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.
[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.
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.
The double-blind sham-controlled study of high-frequency rTMS (20 Hz) for negative symptoms in schizophrenia: negative results. [2006]The high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) over the prefrontal cortex is a promising method for the treatment of negative symptoms of schizophrenia. Using double-blind sham-controlled parallel design, we evaluated the effect of HF-rTMS over the left dorsolateral prefrontal cortex (DLPFC) on negative symptoms in patients with schizophrenia. Sixteen schizophrenia patients with predominantly negative symptoms on stable antipsychotic medication were treated with 20 Hz rTMS (90% of motor threshold, 2000 stimuli per session) over ten days within 2 weeks with six weeks follow-up. The effect was assessed using PANSS, CGI, MADRS and neuropsychological tests. We failed to find any significant effect of active rTMS. Sham rTMS showed a trend for improvement over time on positive and negative subscales of PANSS and MADRS. Between-group comparisons failed to reveal any significant differences on any rating scales except a positive subscale of PANSS after 8 weeks. Results from our study did not confirm that HF-rTMS over the left DLPCF affects the negative symptoms of schizophrenia and alternative rTMS approaches are discussed.
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.
High frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex in schizophrenic patients. [2022]Repetitive transcranial magnetic stimulation (rTMS) has been tried therapeutically in major depression. In order to investigate the therapeutic efficacy of rTMS in psychotic patients, 12 participants (four women, eight men) with schizophrenia according to DSM-IV criteria, aged 25 to 63 years (mean (+/-s.d) 40.4+/-11.0), were enrolled in the study. Following a double-blind crossover design, patients were treated at random with 2 weeks of daily left prefrontal rTMS (20 2s 20 Hz stimulations at 80% motor threshold over 20 min, dorsolateral preforntal cortex) and 2 weeks of sham stimulation. The Brief Psychiatric Rating Scale decreased under active rTMS (p
Safety and Efficacy of Adjunctive ฮ Burst Repetitive Transcranial Magnetic Stimulation to Right Inferior Parietal Lobule in Schizophrenia Patients With First-Rank Symptoms: A Pilot, Exploratory Study. [2022]First-rank symptoms (FRS) in schizophrenia have been found to be associated with various cognitive and biological markers. Repetitive transcranial magnetic stimulation (rTMS) has been shown to modulate such factors. We hypothesized that rTMS adjunctive to antipsychotics will be safe and effective in treatment of FRS in schizophrenia.
A randomized controlled trial of sequentially bilateral prefrontal cortex repetitive transcranial magnetic stimulation in the treatment of negative symptoms in schizophrenia. [2018]Repetitive transcranial magnetic stimulation (rTMS) has been investigated for its treatment efficacy for the negative symptoms of schizophrenia. Previous studies have targeted the dorsolateral prefrontal cortex (DLPFC), which is associated with the pathophysiology of this disorder. Several rTMS parameters have been explored in the treatment of negative symptoms and include stimulating the left and bilateral DLPFC at several different frequencies and number of sessions. Results of such studies have been inconsistent, while high-frequency rTMS has shown greatest promise.