Your session is about to expire
← Back to Search
Behavioural Intervention
Brain Stimulation for Schizophrenia
Sacramento, CA
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 belowSelect...
I am not currently taking the antipsychotic medication clozapine.
Select...
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:Select...
I have a history of neurological or severe psychiatric disorders.
Select...
I have skin conditions like eczema where electrodes would be placed.
Select...
I have experienced a head injury.
Select...
I have epilepsy.
Select...
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.
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 • NCT024834682%
skin irritation
2%
Car accident
100%
80%
60%
40%
20%
0%
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
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.
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.
Find a Location
Closest Location:Imaging Research Center· Sacramento, CA
Who is running the clinical trial?
University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,755,978 Total Patients Enrolled
3 Trials studying Schizophrenia
131 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pacemaker implanted in your body.I have a history of neurological or severe psychiatric disorders.You have vision problems that make it difficult for you to complete cognitive tests or tasks that require distinguishing colors.I have skin conditions like eczema where electrodes would be placed.I am not currently taking the antipsychotic medication clozapine.I have experienced a head injury.I am not currently in need of full-time hospital care.You have metal implants in your body.You have significant intellectual disabilities.I have been diagnosed with schizophrenia or a related disorder.You have a device called an implanted defibrillator in your body.You have been dependent on drugs or alcohol in the last six months.You have used drugs or alcohol heavily in the past month.You have implanted devices that stimulate the brain or spinal cord.I have epilepsy.I have a brain condition.
Research Study Groups:
This trial has the following groups:- Group 1: DLPFC Stimulation + Task
- Group 2: Sham Stimulation + Task
- Group 3: Sham Stimulation + Rest
- Group 4: DLPFC Stimulation + Rest
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.