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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.

Eligibility Criteria

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

I have undergone electroconvulsive therapy.

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

Any implanted devices such as pacemaker, neurostimulator

Timeline

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

Treatment Details

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.

Participant Groups

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+