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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment will begin immediately following stimulation and last for about 1.5 hours.
Awards & highlights
Study Summary
This trial will investigate whether tDCS can improve cognitive functioning in people with schizophrenia. tDCS is a non-invasive technique that delivers a very small electrical current to people's foreheads.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Behavioral Response
EEG Correlates of Language and Cognitive Control
Side effects data
From 2021 Phase 2 & 3 trial • 160 Patients • NCT024834682%
Car accident
2%
skin irritation
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
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,423 Total Patients Enrolled
3 Trials studying Schizophrenia
141 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for me to become involved in this trial?
"To be accepted into the study, potential participants must diagnose with schizophrenia and fall between 18 to 35 years of age. In total, 160 applicants are being admitted."
Answered by AI
How many participants have enrolled in this experiment?
"Yes, information published on clinicaltrials.gov indicates that this trial is now accepting applicants. It was first made public on the 9th of January 2020 and recently updated on July 19 2022 with a goal to recruit 160 patients at one site."
Answered by AI
Is this experiment accepting senior citizens as participants?
"The age range for participants in this medical trial extends from 18 years old to 35 years of age."
Answered by AI
Are there any vacancies remaining for prospective participants of this research project?
"Clinicaltrials.gov records that this medical study is presently accepting applications for participation; it was published on September 1st 2020 and underwent the latest modifications on July 19th 2022."
Answered by AI
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