Transcranial Magnetic Stimulation for Schizophrenia

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KK
Overseen ByKeiko Kunitoki
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial magnetic stimulation (TMS), a non-invasive brain treatment, can reduce negative symptoms such as lack of motivation and emotional withdrawal in individuals with schizophrenia spectrum disorders. Researchers compare the effects of TMS when targeted at different brain areas—the angular gyrus and the prefrontal cortex—against a placebo-like treatment called sham TMS. The study seeks participants diagnosed with a schizophrenia spectrum disorder who experience significant negative symptoms impacting daily life. As an unphased trial, it offers a unique opportunity to contribute to understanding innovative treatments for schizophrenia spectrum disorders.

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 does exclude people taking more than 400 mg of clozapine per day without anti-seizure medication. It's best to discuss your specific medications with the trial staff.

What prior data suggests that transcranial magnetic stimulation is safe for schizophrenia patients?

Research has shown that transcranial magnetic stimulation (TMS) is safe and generally well-tolerated for people with schizophrenia. Individuals with this condition do not have a higher risk of serious side effects, such as seizures, when receiving TMS.

Headaches are the most common side effect, occurring in up to 8% of cases, indicating they are not very frequent. This finding is based on approximately 250 treatment sessions. Overall, TMS maintains a strong safety record for people with schizophrenia.12345

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive way to target specific areas of the brain associated with schizophrenia symptoms. Unlike traditional treatments that often involve medications like antipsychotics, which can have significant side effects and work more broadly, TMS uses magnetic fields to stimulate nerve cells, providing a more targeted approach. Researchers are excited about TMS because it has the potential to improve symptoms with fewer side effects and could offer a new option for those who do not respond well to medications. The hope is that TMS can provide quicker and more precise relief for schizophrenia patients.

What evidence suggests that transcranial magnetic stimulation might be an effective treatment for schizophrenia?

Research has shown that Transcranial Magnetic Stimulation (TMS), which participants in this trial may receive, can help alleviate symptoms of schizophrenia. Studies indicate that TMS can reduce auditory hallucinations, the false sounds patients hear. One study found that TMS is particularly effective at improving negative symptoms, such as lack of emotion or motivation. Reviews suggest that repetitive TMS (rTMS) can enhance thinking skills, memory, and language abilities. Overall, TMS appears to be a promising option for improving various symptoms in people with schizophrenia. Participants in this trial may also receive a sham TMS treatment, serving as a comparator to evaluate TMS's effectiveness.678910

Who Is on the Research Team?

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Xiaoming Du, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with schizophrenia spectrum disorders who have significant negative symptoms, as indicated by a BNSS score of 20 or more. Participants must be under the care of a mental health provider and able to consent. Exclusions include those with certain medical conditions, metal implants near the head, high clozapine doses without anti-seizure meds, substance dependence (except nicotine/marijuana), and women at risk of pregnancy.

Inclusion Criteria

Ability to give written informed consent
Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10
Currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker)
See 2 more

Exclusion Criteria

Failed Transcranial Magnetic Stimulation (TMS) screening questionnaire
I or someone in my family has had deep vein thrombosis.
I have a family member with inherited epilepsy or I answered 'yes' to epilepsy screening questions.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) applied to angular gyrus (AG) or prefrontal cortex (PFC) or sham over 20 treatment visits

4 weeks
20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sham TMS
  • Transcranial Magnetic Stimulation (TMS)

Trial Overview

The study tests if repetitive transcranial magnetic stimulation (rTMS) on the angular gyrus can improve negative symptoms in schizophrenia compared to rTMS on the prefrontal cortex or sham treatment. Patients are randomly assigned to one of these three groups to compare outcomes.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: AG TMSExperimental Treatment1 Intervention
Group II: PFC TMSActive Control1 Intervention
Group III: AG ShamPlacebo Group1 Intervention
Group IV: PFC shamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Citations

Efficacy of Transcranial Magnetic Stimulation (TMS) in the ...

Of the randomized, controlled studies, 10 studies involving a total of 257 subjects with psychosis revealed positive results in treating auditory hallucinations ...

Therapeutic Efficacy of Transcranial Magnetic Stimulation ...

The primary outcome is improvement in negative symptoms related to schizophrenia. The investigators are focusing on negative symptoms given their greater ...

The efficacy of transcranial magnetic stimulation (TMS) for ...

In conclusion, TMS appears to be an efficacious treatment option for patients with schizophrenia suffering from negative symptoms, but the ...

Efficacy of repetitive transcranial magnetic stimulation ...

Most reviews indicate that rTMS has an effect on negative symptoms, executive function, working memory, and language function in patients with schizophrenia.

Repetitive Transcranial Magnetic Stimulation for Auditory ...

The findings of this randomized clinical trial suggest that imaging-navigated rTMS may effectively and safely alleviate AVH in patients with schizophrenia.

Safety of rTMS for Schizophrenia: A Systematic Review ...

rTMS is safe and well tolerated for people with schizophrenia. Individuals with schizophrenia are not at increased risk for adverse effects, including seizure.

Transcranial Magnetic Stimulation (TMS) in Schizophrenia

Headache was the main side effect reported,however, the incidence of headaches after approximately 250 treatment sessions, was found to be as high as 8%.

Deep transcranial magnetic stimulation for schizophrenia

This systematic review suggests that dTMS does not reduce psychotic symptoms in schizophrenia, but it shows potential for improving executive functions.

Theta Burst Stimulation Protocols for Schizophrenia

A recent MRI study found that ECT may reduce positive psychotic symptoms in patients with schizophrenia by preferentially targeting limbic brain ...

Effectiveness of Repetitive Transcranial Magnetic ...

In treatment-resistant depression, repetitive transcranial magnetic stimulation had higher odds of response and remission rates compared to ...