Transcranial Magnetic Stimulation for Schizophrenia
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwell Health
Must be taking: Antipsychotics
Disqualifiers: Substance abuse, Seizure history, others
No Placebo Group
Approved in 3 jurisdictions
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.
12345How 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.
25678Eligibility 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
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TMSExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Zucker Hillside HospitalNew York, NY
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Who Is Running the Clinical Trial?
Northwell HealthLead 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.
Repetitive transcranial magnetic stimulation (rTMS) as an augmentation treatment for the negative symptoms of schizophrenia: a 4-week randomized placebo controlled study. [2022]In the absence of effective treatments for the negative symptom complex of schizophrenia, we explored the effect of 4 consecutive weeks of repetitive transcranial magnetic stimulation (rTMS) exposure (20 sessions) as an add-on treatment to atypical antipsychotics.
Efficacy of non-invasive brain stimulation on the symptom dimensions of schizophrenia: A meta-analysis of randomized controlled trials. [2022]Transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have shown promise in the treatment of schizophrenia.
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
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.
A review of repetitive transcranial magnetic stimulation use in the treatment of schizophrenia. [2022]Patients with schizophrenia often fail to respond to standard antipsychotic medications or have a partial treatment response. Few treatment options are available for these patients. Repetitive transcranial magnetic stimulation (rTMS) was developed and investigated over the last 10 years as a potential treatment option for various psychiatric conditions. Increasingly, studies are focusing on potential applications of rTMS in schizophrenia. To date, most of these studies were symptom-specific rather than focused on the treatment of the disorder in general. The most extensive literature focuses on the use of low-frequency stimulation to attempt to disrupt or reduce the intensity of persistent refractory auditory hallucinations. This research tends to suggest that rTMS could have a role in this subset of patients. There is also preliminary but limited evidence that rTMS could have a role in reducing the negative symptoms of schizophrenia and perhaps in augmenting cognitive function. These findings also highlight the pressing need for further research including multisite studies to confirm the value of these options.