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tDCS for Schizophrenia
N/A
Recruiting
Led By Philip Gerretsen, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate-to-severe lack of illness awareness (≥3 on PANSS G12 Insight and Judgment item)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and post tdcs
Awards & highlights
Study Summary
This trial will study the effects of electrical stimulation on the brains of people with schizophrenia who have difficulty recognizing their illness.
Who is the study for?
This trial is for English-speaking adults over 18 with schizophrenia or schizoaffective disorder, who have a moderate-to-severe lack of illness awareness and are on stable medication. It excludes those taking antiepileptics, with acute suicidal thoughts, pregnant women, serious medical conditions including seizure history, recent substance dependence (except caffeine/nicotine), positive drug screen, MRI contraindications or low WRAT III score.Check my eligibility
What is being tested?
The study tests the effects of transcranial direct current stimulation (tDCS) on illness awareness in schizophrenia patients. Participants will receive either active tDCS or a sham treatment to compare outcomes using clinical assessments and functional imaging techniques.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of tDCS may include mild tingling, itching or discomfort at the electrode sites during stimulation; headache; fatigue; nausea; and insomnia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a moderate-to-severe difficulty recognizing my illness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and weekly for 4 weeks after tdcs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and weekly for 4 weeks after tdcs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Illness awareness
Secondary outcome measures
Neural activity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham TDCSExperimental Treatment1 Intervention
Participants who are randomly assigned to this arm will receive dual hemisphere sham stimulation with electrodes placed on the parietal lobes (P3 and P4) daily for 10 days. Each participant will have two MRI scans and their degree of illness awareness assessed at baseline and after 10 days of tDCS. Illness awareness will be assessed weekly thereafter for 4 weeks.
Group II: Active TDCSExperimental Treatment1 Intervention
Participants who are randomly assigned to this arm will receive dual hemisphere parietal (P3 cathodal, P4 anodal) stimulation daily for 10 days. Each participant will have two MRI scans and their degree of illness awareness assessed at baseline and after 10 days of tDCS. Illness awareness will be assessed weekly thereafter for 4 weeks.
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Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
358 Previous Clinical Trials
82,313 Total Patients Enrolled
58 Trials studying Schizophrenia
4,197 Patients Enrolled for Schizophrenia
Philip Gerretsen, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
260 Total Patients Enrolled
4 Trials studying Schizophrenia
200 Patients Enrolled for Schizophrenia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for epilepsy.I am 18 years old or older.I do not have any serious illnesses or a family history of seizure disorders.I am willing and able to agree to participate in this study.I am on a stable dose of my psychiatric medication with no expected changes.I have a moderate-to-severe difficulty recognizing my illness.
Research Study Groups:
This trial has the following groups:- Group 1: Active TDCS
- Group 2: Sham TDCS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any available openings in this clinical trial?
"Affirmative. Clinicaltrials.gov reports that this clinical trial is presently recruiting candidates, having been posted on August 1st 2016 and most recently amended June 2nd 2022. The total number of participants needed for the study is 34 from a single site."
Answered by AI
What is the total enrollment size of this experiment?
"Affirmative. As per the clinicaltrials.gov documentation, this scientific study is presently searching for volunteers to participate in its research and development; initially posted on August 1st 2016 and last updated June 2nd 2022, it seeks 34 individuals at a solitary medical centre."
Answered by AI
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