What side effects are associated with this type of intervention?

Common treatments for schizophrenia, such as tDCS, rTMS, ECT, and antipsychotic medications, have various side effects. tDCS is generally well-tolerated but can cause mild skin irritation and headaches. rTMS may lead to scalp discomfort, headaches, and, rarely, seizures. ECT can result in short-term memory loss, confusion, and physical side effects like muscle soreness. Antipsychotic medications often cause weight gain, sedation, metabolic changes, and extrapyramidal symptoms such as tremors and rigidity. Each treatment's side effects vary in severity and frequency, and patients should discuss these with their healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for schizophrenia primarily include antipsychotic medications that modulate neurotransmitter levels, particularly dopamine and serotonin. These include first-generation antipsychotics like haloperidol and chlorpromazine, and second-generation antipsychotics such as risperidone, olanzapine, and clozapine. While these medications are effective in managing symptoms, they do not specifically target cognitive deficits. Transcranial Direct Current Stimulation (tDCS) is being studied as a non-invasive method to improve cognitive function by modulating neuronal activity and neurotransmitter levels, offering a potential complementary approach to existing pharmacological treatments.

What other types of research exist?

Promising novel alternatives to tDCS for schizophrenia patients include repetitive transcranial magnetic stimulation (rTMS) and deep brain stimulation (DBS). rTMS has shown potential in improving cognitive function and reducing symptoms in various psychiatric conditions, including schizophrenia. DBS, although more invasive, has been explored for treatment-resistant cases and may offer significant symptom relief. Both methods are under continuous research and may provide viable options for treatment in 2024.

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Behavioural Intervention

Brain Stimulation for Schizophrenia

N/A

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not be currently taking the antipsychotic clozapine

Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder

Must not have

Any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, cerebral palsy, any DSM-5 axis I psychiatric disorder (for healthy control subjects), autism)

Skin damage or skin conditions such as eczema at the sites where electrodes will be placed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessment will begin immediately following stimulation and last for about 1.5 hours.

Summary

This trial is testing whether a small electrical current to the forehead can help improve thinking skills in people with schizophrenia. The study will see if doing this during tasks or at rest makes a difference, and if targeting the front or back of the head is more effective. It also looks at changes in a brain chemical important for thinking. This method has been shown to enhance cognitive performance in both healthy individuals and patients with schizophrenia.

Who is the study for?

This trial is for adults with schizophrenia, schizophreniform or schizoaffective disorder who've had stable medication for the past month and no expected changes in the coming month. They should have a normal IQ, not be on clozapine, able to understand English well enough for cognitive tasks, and capable of informed consent.

What is being tested?

The study tests if transcranial direct current stimulation (tDCS), which applies a small electrical current to the forehead, can improve brain function and cognition in people with schizophrenia during different conditions like rest or task performance.

What are the potential side effects?

While tDCS is generally considered safe and non-invasive, potential side effects may include mild itching, tingling or discomfort at the electrode site; headache; fatigue; nausea; or insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently taking the antipsychotic medication clozapine.

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I have been diagnosed with schizophrenia or a related disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of neurological or severe psychiatric disorders.

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I have skin conditions like eczema where electrodes would be placed.

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I have experienced a head injury.

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I have epilepsy.

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I have a brain condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessment will begin immediately following stimulation and last for about 1.5 hours.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessment will begin immediately following stimulation and last for about 1.5 hours.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment will begin immediately following stimulation and last for about 1.5 hours. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Behavioral Response

EEG Correlates of Language and Cognitive Control

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468

skin irritation

Car accident

100%

80%

60%

40%

20%

Study treatment Arm

tDCS (Active)

tDCS (Sham)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: DLPFC Stimulation + TaskExperimental Treatment1 Intervention

Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during cognitive task completion.

Group II: DLPFC Stimulation + RestExperimental Treatment1 Intervention

Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during rest.

Group III: Sham Stimulation + TaskPlacebo Group1 Intervention

Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during cognitive task completion.

Group IV: Sham Stimulation + RestPlacebo Group1 Intervention

Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during rest.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation

2014

Completed Phase 3

~1100

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia include antipsychotic medications and neuromodulation techniques like transcranial direct current stimulation (tDCS). Antipsychotic medications work by blocking dopamine receptors, particularly D2 receptors, to reduce psychotic symptoms, addressing the overactivity of dopamine pathways in schizophrenia. tDCS, on the other hand, modulates neuronal activity and neurotransmitter levels, including dopamine, by delivering a small electrical current to specific brain regions. This can potentially improve cognitive functions, which are often impaired in schizophrenia patients. Understanding these mechanisms helps in tailoring treatments to target specific symptoms and improve overall functioning.

Increased Neural Activity in Mesostriatal Regions after Prefrontal Transcranial Direct Current Stimulation and l-DOPA Administration.Exploratory study of once-daily transcranial direct current stimulation (tDCS) as a treatment for auditory hallucinations in schizophrenia.