Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mclean Hospital
Disqualifiers: Substance use disorder, Neurological disorder, Seizures, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.
TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for schizophrenia hallucinations?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can significantly reduce symptoms in patients with schizophrenia who experience treatment-resistant auditory hallucinations. In one study, patients receiving rTMS showed better improvement scores compared to those receiving a sham treatment, indicating its potential effectiveness.
12345Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans, with studies indicating it is largely without side effects when used for conditions like schizophrenia.
26789How does TMS treatment differ from other treatments for schizophrenia hallucinations?
TMS (transcranial magnetic stimulation) is unique because it uses magnetic fields to stimulate specific areas of the brain, which can help reduce auditory hallucinations in schizophrenia. Unlike traditional medications, TMS is non-invasive and targets brain activity directly, offering a different approach for patients who do not respond well to standard treatments.
3481011Eligibility Criteria
This trial is for individuals with schizophrenia or schizoaffective disorder. It's not suitable for those who've had substance use disorders recently, have ambidexterity, contraindications to TMS or MRI like neurological issues, head trauma with unconsciousness, seizures/epilepsy (or family history of it), metal in the brain/skull, implanted medical devices, or claustrophobia in MRI.Inclusion Criteria
I have been diagnosed with schizophrenia or schizoaffective disorder.
Exclusion Criteria
I don't have a neurological disorder, head trauma, seizures, epilepsy, metal in my head, implanted devices, or claustrophobia in MRI.
You have had a problem with drugs or alcohol in the past 3 months.
Being able to use both hands equally well.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Baseline Assessment
Participants undergo baseline assessments including PANSS and MRI scans
1 week
1 visit (in-person)
Treatment
Participants undergo five days of twice daily rTMS sessions
1 week
10 visits (in-person)
Follow-up
Participants undergo follow-up MRI imaging and study assessments one week after the last rTMS session
1 week
1 visit (in-person)
Participant Groups
The study tests transcranial magnetic stimulation (TMS) as a noninvasive brain stimulation technique to understand and potentially improve hallucinations in schizophrenia. Participants will receive repetitive TMS (rTMS) or a sham version that mimics the procedure without actual stimulation.
2Treatment groups
Active Control
Placebo Group
Group I: Active cerebellum rTMSActive Control1 Intervention
Cerebellar targeted iTBS, twice daily, one week.
Group II: Sham cerebellum rTMSPlacebo Group1 Intervention
Cerebellar targeted sham iTBS, twice daily, one week.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McLean HospitalBelmont, MA
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Who Is Running the Clinical Trial?
Mclean HospitalLead Sponsor
Beth Israel Deaconess Medical CenterCollaborator
National Institute of Mental Health (NIMH)Collaborator
References
A double blind study showing that two weeks of daily repetitive TMS over the left or right temporoparietal cortex reduces symptoms in patients with schizophrenia who are having treatment-refractory auditory hallucinations. [2022]The aim of this study was to evaluate the effect of repetitive transcranial magnetic stimulation (rTMS) on the left and right temporoparietal cortex compared with sham stimulation in schizophrenic patients with treatment-refractory auditory hallucinations (AH). Thirty-nine patients with schizophrenia with treatment-refractory AH were allocated randomly to one of three groups: daily left, right, and sham rTMS groups. rTMS was applied to the TP3 or 4 regions with the aid of the electroencephalography 10-20 international system at 1 Hz for 20 min per day for 10 treatment days. Symptoms were evaluated using the Auditory Hallucination Rating Scale (AHRS), the Positive and Negative Symptoms Scale (PANSS), the Clinical Global Impression--Severity (CGI-S), and Clinical Global Impression--Improvement (CGI-I) scale. For the time effect (within-subject comparison), there were significant changes in the frequency of AHs, positive symptoms of PANSS, and CGI-I. A between-group comparison revealed significant differences in the positive symptoms of PANSS, and CGI-I scores. Post hoc analysis revealed that both the right- and left-side rTMS treatment groups exhibited better CGI-I scores compared to the sham-stimulated group. This study suggests that 10 days of low-frequency rTMS applied daily for 20 min to either temporoparietal cortex significantly reduces the symptoms in patients with schizophrenia who are having refractory AH, but the left sided rTMS is not superior to right or sham rTMS.
Left prefrontal repetitive transcranial magnetic stimulation in schizophrenia. [2022]In a double-blind, controlled study, we examined the therapeutic effects of high-frequency left prefrontal repetitive transcranial magnetic stimulation (rTMS) on schizophrenia symptoms. A total of 22 chronic hospitalized schizophrenia patients were randomly assigned to 2 weeks (10 sessions) of real or sham rTMS. rTMS was given with the following parameters: 20 trains of 5-second 10-Hz stimulation at 100 percent motor threshold, 30 seconds apart. Effects on positive and negative symptoms, self-reported symptoms, rough neuropsychological functioning, and hormones were assessed. Although there was a significant improvement in both groups in most of the symptom measures, no real differences were found between the groups. A decrease of more than 20 percent in the total PANSS score was found in 7 control subjects but only 1 subject from the real rTMS group. There was no change in hormone levels or neuropsychological functioning, measured by the MMSE, in either group. Left prefrontal rTMS (with the used parameters) seems to produce a significant nonspecific effect of the treatment procedure but no therapeutic effect in the most chronic and severely ill schizophrenia patients.
Repetitive Transcranial Magnetic Stimulation in Resistant Visual Hallucinations in a Woman With Schizophrenia: A Case Report. [2020]A 29-year-old woman with schizophrenia introduced for application of repetitive transcranial magnetic stimulation for refractory visual hallucinations. Following inhibitory rTMS on visual cortex she reported significant reduction in severity and simplification of complexity of hallucinations, which lasted for three months. rTMS can be considered as a possibly potent treatment for visual hallucinations.
Effect of augmentatory repetitive transcranial magnetic stimulation on auditory hallucinations in schizophrenia: randomized controlled study. [2013]Auditory hallucinations are a characteristic symptom of schizophrenia and are usually resistant to treatment. The present study was conducted to further support the findings that repetitive transcranial magnetic stimulation (rTMS) reduces auditory hallucinations, and to evaluate the effect of low-frequency rTMS on auditory hallucinations in schizophrenia.
[The use of repetitive transcranial magnetic stimulation (rTMS) in auditory verbal hallucinations (AVH)]. [2010]Up to one-third of all schizophrenic patients suffer from auditory verbal hallucinations (AVH) that are resistant to antipsychotics. The use of repetitive transcranial magnetic stimulation (rTMS) is a therapeutic option that may disrupt or attenuate treatment resistant (TR) AVHs. This article reviews the available literature on the use of rTMS to treat AVHs, particularly focusing on randomised controlled trials, which have introduced new definitions ("refractory AVHs"), and techniques (active comparator strategies and imaging-guided rTMS). A number of meta-analyses are considered, which support a range of positive effect sizes for AVH attenuation in response to rTMS. Larger maintenance and follow-up studies with clearer clinical definitions of TR AVH are required. The underlying mechanism of action of rTMS on language networks needs further clarification and future trials should focus on methods for assessing AVH changes, time courses of response, and the development of response markers.
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.
[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.
Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. [2022]Auditory hallucinations are often resistant to treatment and can produce significant distress and behavioral difficulties. A preliminary report based on 24 patients with schizophrenia or schizoaffective disorder indicated greater improvement in auditory hallucinations following 1-hertz left temporoparietal repetitive transcranial magnetic stimulation (rTMS) compared to sham stimulation. Data from the full 50-subject sample incorporating 26 new patients are now presented to more comprehensively assess safety/tolerability, efficacy and moderators of this intervention.
[Non-invasive brain stimulation in schizophrenia: hallucinations and negative symptoms]. [2018]New approaches are needed in the treatment of characteristic symptoms of schizophrenia such as hallucinations and negative symptoms. Non-invasive brain stimulation can make a useful contribution. AIM: To discuss the published evidence regarding efficacy and safety of repetitive transcranial magnetic stimulation (rtms) and transcranial direct current stimulation (tdcs) when used in the treatment of auditory verbal hallucinations and negative symptoms. METHOD: We review and discuss recent meta-analyses and we analyse relevant factors. RESULTS: On average, when compared to sham-stimulation, rtms was found to have a significant effect on hallucinations and negative symptoms. Nevertheless, the results of some studies were variable and some studies did not report any improvement. There are indications that some factors such as age and distance between scalp and cortex may influence efficiency. There were only a few studies relating to the use of tdcs and none of these reported a clear effect. CONCLUSION: There is reasonable evidence that rtms is an efficient treatment for hallucinations and negative symptoms, although some variable results have been reported. There is insufficient evidence for conclusions to be drawn about the efficacy of tdcs for the treatment of hallucinations and negative symptoms. However, both simulation methods are safe and largely without side-effects.
A systematic review and meta-analysis of the use of repetitive transcranial magnetic stimulation for auditory hallucinations treatment in refractory schizophrenic patients. [2022]The use of repetitive transcranial magnetic stimulation (rTMS) remains a promising therapeutic tool in the treatment of schizophrenia. Symptoms such as auditory hallucinations (AH) find contradictory results in many studies. Here we present an up-to-date systematic review and meta-analysis of rTMS in the treatment of AH in 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.