Neural Stimulation for Schizophrenia

Overseen By Linlin Fan

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Epilepsy, Seizures, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial Direct Current Stimulation (tDCS), a gentle brain stimulation method, can reduce psychotic symptoms and improve daily life for individuals with schizophrenia or schizoaffective disorder. Participants will receive either real or sham (fake) tDCS sessions to compare effects. The trial targets individuals diagnosed with schizophrenia or schizoaffective disorder who have recently experienced paranoia. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

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 transcranial Direct Current Stimulation (tDCS) is safe for individuals with schizophrenia?

Research has shown that transcranial Direct Current Stimulation (tDCS) is generally safe for people with schizophrenia. In several studies, participants tolerated tDCS well, with the most common side effects being mild, such as itching or tingling on the skin where the device was placed.

One study found that tDCS helped reduce negative symptoms in patients and was both effective and safe. Another study confirmed that tDCS served as a safe additional treatment for those with schizophrenia, with no major safety concerns.

Overall, research indicates that tDCS is a safe option for people with schizophrenia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for schizophrenia, like antipsychotic medications, work by altering neurotransmitter activity in the brain. However, tDCS, or transcranial Direct Current Stimulation, offers a non-invasive method that uses a mild electrical current to modulate brain activity directly. Unlike traditional medication, which can have side effects like weight gain or drowsiness, tDCS is generally well-tolerated and has minimal side effects. Researchers are excited about tDCS because it has the potential to improve symptoms of schizophrenia quickly and safely, offering a new avenue for patients who may not respond well to medications.

What evidence suggests that tDCS is effective for schizophrenia?

Research shows that transcranial Direct Current Stimulation (tDCS) can improve thinking skills in people with schizophrenia. Studies have found that tDCS might assist with tasks like learning words and other mental activities. Some research even suggests that the benefits of tDCS can continue for some time after treatment ends. It has proven both effective and safe, especially for those with symptoms like low motivation or reduced emotional expression. While results can differ, tDCS offers promising potential for people with schizophrenia. Participants in this trial will receive either active anodal tDCS followed by sham tDCS, or sham tDCS followed by active anodal tDCS, to evaluate the effects of this treatment. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with schizophrenia or schizoaffective disorder experiencing recent paranoia. It's not suitable for pregnant individuals, those with certain developmental disorders, neurological conditions like epilepsy, active substance use disorders, severe sensory impairments, a history of electroconvulsive therapy, non-English speakers, or anyone with implanted medical devices.

Inclusion Criteria

Diagnosed with schizophrenia or schizoaffective disorder

I have experienced paranoia in the last month.

Exclusion Criteria

Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ < 70

Lack of proficiency in English

Substance use disorder not in remission in the past 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active anodal tDCS or sham tDCS followed by behavioral testing, with a crossover design and a washout period of about 1 week between sessions

2 weeks

Multiple visits for tDCS sessions and assessments

Follow-up

Participants are monitored for changes in paranoia and social functioning using Ecological Momentary Assessments (EMA) before and after stimulation

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study investigates if brain stimulation through transcranial Direct Current Stimulation (tDCS) can alleviate psychotic symptoms and improve social functioning in people with schizophrenia spectrum disorders.

How Is the Trial Designed?

Group I: Active anodal tDCS first, then Sham tDCS Experimental Treatment 1 Intervention

Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.

Group II: Sham tDCS first, then Active anodal tDCS Placebo Group 1 Intervention

Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

Citations

1. nature.com nature.com/articles/s41537-025-00647-5

Investigating the effects of transcranial direct current ... While preliminary, these findings indicate that tDCS could support cognitive training outcomes in schizophrenia. Larger randomized controlled ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11541428/

Transcranial direct current stimulation and its effect on ... Recent studies indicate that tDCS can significantly improve cognitive functioning in individuals with schizophrenia, with effects persisting ...

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2752388

Efficacy and Safety of Transcranial Direct Current ... Frontotemporoparietal tDCS was an effective and safe add-on treatment for patients with schizophrenia with prominent negative symptoms. Our ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584625002805

Transcranial direct current stimulation (tDCS) for cognitive ... tDCS shows domain-specific potential for cognitive enhancement in schizophrenia, particularly in verbal learning. However, the small effect ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1617068/full

Adjunctive transcranial direct current stimulation for ... Discussion: This exploratory meta-analysis revealed that tDCS in the treatment of schizophrenia appears capable of improving cognitive function and effectively ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31617873/

Efficacy and Safety of Transcranial Direct Current ... Transcranial direct current stimulation was effective and safe in ameliorating negative symptoms in patients with schizophrenia.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40228176/

Safety and Blinding of Transcranial Direct Current ... This study confirms that tDCS is safe and well tolerated by patients with schizophrenia. The most frequent side effects are itching/tingling ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2215001324000362

Transcranial direct current stimulation and its effect on ... Recent studies indicate that tDCS can significantly improve cognitive functioning in individuals with schizophrenia, with effects persisting beyond the ...