Brain Stimulation for Schizophrenia

ST
Overseen ByStudy Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
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 new ways to treat schizophrenia, a challenging mental health condition marked by delusions, hallucinations, and cognitive issues. Researchers are testing whether connectivity-guided theta burst brain stimulation (TBS) can improve brain function in people with schizophrenia by targeting the hippocampus, an area involved in the disorder. The trial will compare active brain stimulation with sham (inactive) stimulation to determine if the real treatment makes a difference. The study seeks participants diagnosed with schizophrenia or related disorders who do not have major neurological issues other than epilepsy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for schizophrenia.

Do I need to stop my current medications for the trial?

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 prior data suggests that connectivity-guided theta burst brain stimulation is safe for schizophrenia?

Research has shown that theta burst stimulation (TBS) can be a safe treatment for schizophrenia, though some risks exist. For TBS using direct electrical stimulation, studies have not identified major safety issues, but detailed information remains limited.

In contrast, TBS using transcranial magnetic stimulation (TMS) has occasionally led to serious side effects, such as mania (very high energy or mood) and psychosis (difficulty distinguishing reality), which might be related to the treatment. However, these side effects are rare, and most patients tolerate this type of brain stimulation well.

Overall, while TBS can have some side effects, it is generally well-tolerated. Those interested in these treatments should discuss the potential risks and benefits with their medical team.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for schizophrenia because they use innovative brain stimulation techniques that could offer new hope for patients. Unlike typical antipsychotic medications, which often target neurotransmitters like dopamine, connectivity-guided theta burst brain stimulation (TBS) directly targets brain circuits involved in the condition. This trial explores both invasive and noninvasive methods: direct electrical stimulation through intracranial electrodes and transcranial magnetic stimulation (TMS) that offers a noninvasive alternative. These approaches aim to modulate brain activity more precisely and potentially provide faster relief from symptoms compared to traditional medications.

What evidence suggests that this trial's brain stimulation techniques could be effective for schizophrenia?

Studies have shown that theta burst stimulation (TBS) could be a promising way to treat symptoms of schizophrenia. In this trial, participants may receive either direct electrical stimulation or transcranial magnetic stimulation (TMS) using a theta burst pattern. Research indicates that both methods effectively manage symptoms like hallucinations and thinking problems. Some findings suggest that TBS can specifically target brain areas involved in these symptoms, potentially improving patient outcomes. Additionally, faster TBS with personalized targeting has effectively reduced negative symptoms, which are often hard to treat. While some side effects, such as mania and psychosis, have been noted, these treatments are generally considered safe and acceptable.24678

Who Is on the Research Team?

EA

Ethan A Solomon, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 65 with schizophrenia spectrum disorders, including delusional disorder and schizoaffective disorder. It's also open to those with medically intractable epilepsy for certain study arms. Participants must understand the study risks to give informed consent and have no major neurological issues besides epilepsy.

Inclusion Criteria

I have been diagnosed with a schizophrenia spectrum disorder.
I need special brain monitoring for my hard-to-treat epilepsy.
I am between 18 and 65 years old.
See 2 more

Exclusion Criteria

Significant head injury
Inability to provide informed consent
Active suicidal ideation or history of suicide attempt within the past 1 year
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive theta burst brain stimulation targeting hippocampal function

1 session
1 visit (in-person)

Follow-up

Participants are monitored for changes in EEG power after TBS session

45 minutes
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Connectivity-guided Theta Burst Brain Stimulation
Trial Overview The trial tests if brain stimulation techniques like transcranial magnetic stimulation (TMS) can influence hippocampal activity in schizophrenia patients. It involves using intracranial electrodes or TMS, including a sham procedure as a control comparison.
How Is the Trial Designed?
4Treatment groups
Active Control
Placebo Group
Group I: TBS via direct electrical stimulationActive Control1 Intervention
Group II: TBS via transcranial magnetic stimulationActive Control1 Intervention
Group III: Sham TBS via direct electrical stimulationPlacebo Group1 Intervention
Group IV: Sham TBS via transcranial magnetic stimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39999247/
Connectivity guided intermittent theta burst stimulation ...One serious adverse event in each group (mania, psychosis) was attributable to transcranial magnetic stimulation. Both treatments were equally acceptable ...
Theta Burst Stimulation Protocols for SchizophreniaSchizophrenia, a severe mental illness affecting approximately 1% of the population, is characterized by positive, negative, cognitive, and ...
Connectivity-guided intermittent theta burst versus ...Two serious adverse events were possibly related to TMS (mania and psychosis). MRI-neuronavigated cgiTBS and rTMS were equally effective in ...
The efficacy and safety of continuous theta burst ...Objective: Auditory hallucinations are the most frequently occurring psychotic symptom in schizophrenia. Continuous theta burst stimulation ...
Accelerated iTBS with a personalised targeting method to ...Accelerated iTBS targeting the personalised region determined by dlPFC-VTA FC is an effective intervention to alleviate negative symptoms of schizophrenia.
Theta Burst Stimulation Protocols for SchizophreniaSchizophrenia, a severe mental illness affecting approximately 1% of the population, is characterized by positive, negative, cognitive, and ...
NCT03288779 | Theta Burst Stimulation for SchizophreniaThe purpose of this study is to evaluate the effect of TBS on WM in patients with schizophrenia, to develop evidence for potential brain stimulation techniques ...
A Systematic Review of the Safety and Tolerability of Theta ...A 15-year-old female patient with schizophrenia (diagnosed with a clinical interview) was enrolled in a neurophysiological study arm meant to deliver 600 pulses ...
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