Magnetic Stimulation for Schizophrenia
Recruiting in Palo Alto (17 mi)
Overseen ByXiaoming Du, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Must not be taking: Clozapine
Disqualifiers: Seizures, Unstable medical illnesses, Alcohol/drug use, others
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.
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 for schizophrenia?
Some studies suggest that repetitive transcranial magnetic stimulation (rTMS) can improve negative symptoms in schizophrenia, especially when used as an additional treatment. However, results are mixed, and not all studies show significant benefits.
12345Is magnetic stimulation 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, without major safety concerns.
12567How is the treatment Active H-coil rTMS different from other treatments for schizophrenia?
Active H-coil rTMS (repetitive transcranial magnetic stimulation) is unique because it uses magnetic fields to stimulate specific areas of the brain, like the prefrontal cortex, to improve symptoms of schizophrenia, particularly negative symptoms. Unlike traditional medications, this treatment is non-invasive and focuses on altering brain activity directly rather than affecting chemical balances.
12589Eligibility Criteria
This trial is for men and women aged 18-60 with schizophrenia-spectrum disorder who can consent to participate. It's not for lab employees, those unable to avoid alcohol/marijuana before experiments, people with significant head injuries or brain conditions, severe drug users, individuals with a history of seizures or thrombosis risks, those on high doses of clozapine (>400 mg/day), or pregnant women.Inclusion Criteria
I am between 18 and 60 years old.
I am 18 or older and can sign a consent form.
Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10
Exclusion Criteria
Students and employees currently involved with the lab (lab employees and personnel will be excluded from the study)
Failed TMS screening questionnaire
Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive active repetitive transcranial magnetic stimulation (rTMS) treatment with H coil
2 weeks
Follow-up
Participants are monitored for changes in brain microstructural integrity, resting-state functional connectivity, cognitive functions, and electrophysiological responses
4 weeks
Participant Groups
The study tests if active repetitive transcranial magnetic stimulation (rTMS) using an H-coil can improve white matter integrity in patients with schizophrenia spectrum disorder. The goal is to enhance brain connectivity through neuromodulation.
1Treatment groups
Experimental Treatment
Group I: Active rTMSExperimental Treatment1 Intervention
Participants in this group will receive active H-coil delivered rTMS.
Active H-coil rTMS is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as rTMS for:
- Treatment-resistant depression
- Schizophrenia (negative symptoms)
🇺🇸 Approved in United States as rTMS for:
- Treatment-resistant depression
- Obsessive-compulsive disorder (OCD)
🇨🇦 Approved in Canada as rTMS for:
- Treatment-resistant depression
- Schizophrenia (negative symptoms)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center, HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
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.
[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.
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.
[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.
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.
The tolerability of rTMS treatment in schizophrenia with respect to cognitive function. [2010]The purpose of this study was to assess tolerability and safety of high-frequency rTMS with regard to cognitive performance when conducted as "add-on" treatment in chronic schizophrenia in-patients (n=32).
Deep transcranial magnetic stimulation for the treatment of auditory hallucinations: a preliminary open-label study. [2021]Schizophrenia is a chronic and disabling disease that presents with delusions and hallucinations. Auditory hallucinations are usually expressed as voices speaking to or about the patient. Previous studies have examined the effect of repetitive transcranial magnetic stimulation (TMS) over the temporoparietal cortex on auditory hallucinations in schizophrenic patients. Our aim was to explore the potential effect of deep TMS, using the H coil over the same brain region on auditory hallucinations.
Efficacy of high-frequency repetitive transcranial magnetic stimulation on PANSS factors in schizophrenia with predominant negative symptoms - Results from an exploratory re-analysis. [2018]Repetitive transcranial magnetic stimulation (rTMS) applied to the left frontal lobe is discussed to be a promising add-on treatment for negative symptoms in schizophrenia. The Positive and Negative Syndrome Scale (PANSS) has been used as outcome parameter in several previous rTMS trials, but studies focusing on PANSS factor analyses are lacking. For this purpose, we used the available PANSS data of the 'rTMS for the Treatment of Negative Symptoms in Schizophrenia' (RESIS) trial to calculate different literature-based PANSS factors and to re-evaluate the impact of rTMS on negative symptoms in this trial. In an exploratory re-analysis of published data from the RESIS study (Wobrock et al. 2015), we tested the impact of rTMS applied to the left dorsolateral prefrontal cortex on two PANSS factors for negative symptoms in psychotic disorders as well as on a PANSS five-factor consensus model intending to show that active rTMS treatment improves PANSS negative symptom subscores. In accordance to the original analysis, all PANSS factors showed an improvement over time in the active and, to a considerable extent, also in the sham rTMS group. However, comparing the data before and directly after the rTMS intervention, the PANSS excitement factor improved in the active rTMS group significantly more than in the sham group, but this finding did not persist if follow-up data were taken into account. These additional analyses extend the previously reported RESIS trial results showing unspecific improvements in the PANSS positive subscale in the active rTMS group. Our PANSS factor-based approach to investigate the impact of prefrontal rTMS on different negative symptom domains confirmed no overall beneficial effect of the active compared to sham rTMS.