Magnetic Stimulation for Schizophrenia

Overseen By Xiaoming Du, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called repetitive transcranial magnetic stimulation (rTMS), which uses magnetic pulses to potentially improve brain health in individuals with schizophrenia spectrum disorder. Researchers aim to enhance connections in the brain's white matter, which could benefit those living with the condition. Individuals diagnosed with schizophrenia who can give consent might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for schizophrenia.

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 prior data suggests that this magnetic stimulation technique is safe for patients with schizophrenia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is safe and well-tolerated for people with schizophrenia. Studies indicate that people with schizophrenia do not face a higher risk of side effects, such as seizures, when using rTMS. This suggests the treatment is generally safe, and most people handle it well. For those considering joining a clinical trial with rTMS, this information indicates that the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about active H-coil rTMS for schizophrenia because it offers a non-invasive approach to treatment by using magnetic fields to stimulate specific areas of the brain. Unlike traditional antipsychotic medications that target neurotransmitter imbalances, rTMS directly influences brain activity with precision, potentially reducing symptoms without the common side effects associated with medications. This method of delivery is unique and represents a shift towards using technology to manage schizophrenia, potentially offering faster relief and improving quality of life for patients.

What evidence suggests that this magnetic stimulation is effective for schizophrenia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) using the H-coil may help with schizophrenia. One study found that rTMS was more effective than a placebo in reducing auditory hallucinations in people with schizophrenia. Other research also reported a significant decrease in these hallucinations for patients who received rTMS. While results can vary, these findings suggest that rTMS might improve symptoms for those with schizophrenia spectrum disorder. Participants in this trial will receive active H-coil delivered rTMS to further evaluate its effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

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 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

Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10

Exclusion Criteria

Failed TMS screening questionnaire

Students and employees currently involved with the lab (lab employees and personnel will be excluded from the study)

Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Active H-coil rTMS

Trial Overview 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.

How Is the Trial Designed?

Group I: Active rTMS Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

High dose transcranial magnetic stimulation (rTMS) at 10 Hz significantly reduced negative symptoms in schizophrenia patients, particularly blunted affect, emotional withdrawal, and passive/apathetic social withdrawal, with an effective rate of 43.75% compared to 11.43% in the control group.

While rTMS was found to be effective, it was associated with a higher incidence of headaches (37.50% in the study group) compared to the control group, indicating a need for monitoring side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of high dose transcranial magnetic stimulation in schizophrenia with refractory negative symptoms: a randomized controlled study]. Gan, J., Duan, H., Chen, Z., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) combined with antipsychotic treatment has been shown to slightly improve negative symptoms in schizophrenia patients, based on a meta-analysis of 29 studies involving 1440 participants.

While rTMS treatment is generally well-accepted and has fewer adverse effects, it is associated with a higher rate of mild side effects, indicating the need for careful consideration in its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. Wang, J., Zhou, Y., Gan, H., et al.[2020]

Deep transcranial magnetic stimulation (TMS) applied to the left temporoparietal cortex showed a significant average reduction of 31.7% in auditory hallucination severity among eight schizophrenic patients with refractory symptoms, indicating its potential efficacy as a treatment.

The study also noted a lesser improvement in overall positive symptoms of schizophrenia, suggesting that deep TMS may help alleviate specific symptoms like auditory hallucinations, warranting further investigation with larger, controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep transcranial magnetic stimulation for the treatment of auditory hallucinations: a preliminary open-label study. Rosenberg, O., Roth, Y., Kotler, M., et al.[2021]

Bimodal repetitive transcranial magnetic stimulation (rTMS) significantly reduced symptoms of schizophrenia in 10 patients who were unresponsive to medication, with improvements noted in all subscales of the Positive and Negative Syndrome Scale (PANSS) by Day 29.

The treatment also showed potential benefits for short-term auditory verbal memory, as indicated by significant increases in neurocognitive test scores after the rTMS sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study. Oh, SY., Kim, YK.[2011]

Rhythmic transcranial magnetic stimulation (rTMS) showed significant efficacy in reducing symptoms of resistant schizophrenia, particularly in patients with depressive, hallucinatory, and negative symptoms, with reductions in PANSS scores of 24.4%, 8.3%, and 11.7% respectively after 15 sessions over 3 weeks.

However, rTMS was not effective for patients with delusional symptoms, leading to a worsening of their condition, indicating that treatment must be tailored to the specific symptoms of schizophrenia for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Augmentation therapy of resistant schizophrenia with rhythmic transcranial magnetic stimulation]. Pomytkin, AN., Tikhonov, DV., Kaleda, VG.[2023]

In a study involving 16 patients with schizophrenia, high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) over the left dorsolateral prefrontal cortex did not show significant effects on negative symptoms compared to sham treatment.

While there was a trend for improvement in some symptoms with sham rTMS, the study concluded that HF-rTMS is not effective for treating negative symptoms of schizophrenia, suggesting the need for exploring alternative rTMS methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The double-blind sham-controlled study of high-frequency rTMS (20 Hz) for negative symptoms in schizophrenia: negative results. Novák, T., Horácek, J., Mohr, P., et al.[2006]

In a study involving 32 chronic schizophrenia in-patients, high-frequency rTMS (10 Hz) applied over two weeks did not lead to any significant deterioration in cognitive performance, indicating good tolerability of the treatment.

Patients with poorer baseline performance on cognitive tests showed improvement in psychopathology after rTMS treatment, suggesting potential benefits for cognitive function in certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The tolerability of rTMS treatment in schizophrenia with respect to cognitive function. Mittrach, M., Thünker, J., Winterer, G., et al.[2010]

In a re-analysis of the RESIS trial data, repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex showed a significant improvement in the PANSS excitement factor immediately after treatment compared to the sham group, although this effect did not last in follow-up assessments.

Overall, the study found no significant long-term benefits of active rTMS over sham treatment for negative symptoms in schizophrenia, suggesting that while there may be short-term improvements, rTMS may not provide a sustained therapeutic advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of high-frequency repetitive transcranial magnetic stimulation on PANSS factors in schizophrenia with predominant negative symptoms - Results from an exploratory re-analysis. Hansbauer, M., Wobrock, T., Kunze, B., et al.[2018]

In a study involving 10 right-handed schizophrenia patients, active repetitive transcranial magnetic stimulation (rTMS) at 10 Hz significantly improved negative symptoms of schizophrenia compared to sham treatment.

The improvement in negative symptoms occurred independently of any changes in depressive symptoms, suggesting that rTMS specifically targets negative symptoms in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Goyal, N., Nizamie, SH., Desarkar, P.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11176548/

Deep transcranial magnetic stimulation for schizophrenia Active dTMS was comparable to the sham treatment in improving total psychopathology, positive symptoms, negative symptoms, and auditory hallucinations.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00564096

Transcranial Magnetic Stimulation (TMS) in Schizophrenia Deep TMS is using this h-coil. Auditory hallucinations are reported by 50% to 70% of patients with schizophrenia and generally consist of spoken speech or " ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825941

Repetitive Transcranial Magnetic Stimulation for Auditory ... Findings In this randomized clinical trial of 62 patients with schizophrenia and AVH, active rTMS was superior to sham treatment in alleviating ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S002239562400270X

Clinical efficacy of deep transcranial magnetic stimulation ... We systematically reviewed 28 clinical trials comparing active dTMS to a sham/controlled condition to characterize dTMS efficacy across diverse psychiatric and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4558786/

Efficacy of Transcranial Magnetic Stimulation (TMS) in the ... Brunelin et al reported significant reduction in auditory hallucinations in 24 right-handed, treatment-refractory patients with schizophrenia who were treated ...

6. academic.oup.com academic.oup.com/schizophreniabulletin/article/51/2/392/7758322

Safety of rTMS for Schizophrenia: A Systematic Review and ... rTMS is safe and well tolerated for people with schizophrenia. Individuals with schizophrenia are not at increased risk for adverse effects, including seizure.

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1390913/full

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.