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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 5 6 7}

How 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. ^{1 2 5 8 9}

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.

Research Team

Xiaoming Du, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2007]

2. China pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of high dose transcranial magnetic stimulation in schizophrenia with refractory negative symptoms: a randomized controlled study]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Augmentation therapy of resistant schizophrenia with rhythmic transcranial magnetic stimulation]. [2023]

5. Sweden pubmed.ncbi.nlm.nih.gov

The double-blind sham-controlled study of high-frequency rTMS (20 Hz) for negative symptoms in schizophrenia: negative results. [2006]

6. China pubmed.ncbi.nlm.nih.gov

Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

The tolerability of rTMS treatment in schizophrenia with respect to cognitive function. [2010]

8. England pubmed.ncbi.nlm.nih.gov

Deep transcranial magnetic stimulation for the treatment of auditory hallucinations: a preliminary open-label study. [2021]

9. Ireland 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. [2018]