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Brain Stimulation
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
Be between 18 and 65 years old
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 studying how well transcranial direct current stimulation (tDCS) works in improving higher-order cognition in people with and without schizophrenia.
Who is the study for?
This trial is for adults with schizophrenia, schizophreniform or schizoaffective disorder who have stable mental health, no recent medication changes, and a normal IQ. They must not be on clozapine, pregnant, have uncorrected vision issues that affect testing or skin conditions at electrode sites. Participants should not have substance abuse history in the last month or metal implants.
What is being tested?
The study tests how brain function related to higher-order cognition (like language comprehension and memory) is affected by transcranial direct current stimulation (tDCS). It compares the effects of tDCS on different brain regions using behavioral tasks and EEG monitoring in both healthy individuals and those with schizophrenia.
What are the potential side effects?
Potential side effects from tDCS may include discomfort at the electrode site, itching, tingling during application, headache after treatment sessions, fatigue or nausea. Serious risks are rare but can include seizures or skin burns.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Behavioral Response (Cognitive Control Task)
Behavioral Response (Language Task)
EEG Correlates of Language and Cognitive Control
Side effects data
From 2021 Phase 2 & 3 trial • 160 Patients • NCT024834682%
skin irritation
2%
Car accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: DLPFC StimulationExperimental Treatment1 Intervention
Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex.
Group II: Occipital StimulationActive Control1 Intervention
Intervention. 20 minutes of 2 mA direct current stimulation over the occipital cortex.
Group III: Sham StimulationPlacebo Group1 Intervention
Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,755,568 Total Patients Enrolled
3 Trials studying Schizophrenia
171 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have vision problems that would make it difficult for you to complete cognitive tests. This includes color blindness if the test requires the ability to see different colors.You are pregnant.You have skin damage, such as eczema, where the electrodes will be placed.You have been diagnosed with schizophrenia, schizophreniform or schizoaffective disorder.You have implanted devices that use electricity to stimulate your brain or spine.You have a device called a defibrillator implanted in your body.You have metal implants in your body.You have a problem with your brain.You have had a head injury.You have epilepsy.You have a history of neurological disorders such as epilepsy, ALS, MS, stroke, cerebral palsy, or any psychiatric disorder listed in DSM-5 (for healthy control subjects), or autism.You have been addicted to drugs or alcohol within the last six months.You have a pacemaker.You have used drugs or alcohol in the last month.You have a developmental disability that affects intellectual functioning.You have been stable for at least 3 months.You have no medication changes in the prior month.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Stimulation
- Group 2: DLPFC Stimulation
- Group 3: Occipital Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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