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tDCS + Cognitive Remediation for Schizophrenia
N/A
Recruiting
Led By Michael W Best, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
Awards & highlights
Study Summary
This trialwill study whether combining Transcranial direct current stimulation (tDCS) with cognitive remediation can improve cognitive abilities in those with schizophrenia-spectrum disorders.
Who is the study for?
This trial is for adults aged 18-65 with schizophrenia or related psychotic disorders, who are not currently abusing drugs or alcohol. Participants must speak English, be able to use a computer, and not have any recent cognitive training. Pregnant individuals, those with seizure disorders, neurological diseases or damage, significant medical illnesses affecting brain function, or severe head injuries are excluded.Check my eligibility
What is being tested?
The study tests if Transcranial direct current stimulation (tDCS) can boost the effectiveness of executive function training in improving cognitive abilities in people with schizophrenia-spectrum disorders. Half will receive real tDCS while the other half get a sham treatment; all participants will undergo cognitive remediation.See study design
What are the potential side effects?
Potential side effects of tDCS may include mild tingling on the scalp, itching under the electrode site during stimulation, headache after sessions and fatigue. Serious risks like seizures are rare but possible especially in susceptible individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Specific Levels of Functioning (SLOF)
Secondary outcome measures
Brief Core Schema Scale (BCSS)
Brief Psychiatric Rating Scale (BPRS)
Cambridge Neuropsychological Test Automated Battery (CANTAB)
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Actual tDCs + ETExperimental Treatment2 Interventions
All interventions will involve 4 weeks of group intervention consisting of two 1-hour group sessions per week and additional practice between sessions. Half of study participants will be randomized to receive 30 minutes of transcranial direct current stimulation (tDCS) prior to beginning each ET session. ET session will begin immediately after tDCS.
Group II: Sham tDCs + ETPlacebo Group1 Intervention
All interventions will involve 4 weeks of group intervention consisting of two 1-hour group sessions per week and additional practice between sessions. Half of study participants will be randomized to receive 30 minutes of sham transcranial direct current stimulation (tDCS) prior to beginning each ET session. ET session will begin immediately after tDCS. During the sham tDCS, the procedures will be exactly the same as the real tDCS (e.g., application of electrodes), however, no stimulation will be provided when the device turned on.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Executive function training
2018
N/A
~50
Transcranial direct current stimulation
2012
Completed Phase 3
~650
Find a Location
Who is running the clinical trial?
University of TorontoLead Sponsor
689 Previous Clinical Trials
1,018,603 Total Patients Enrolled
4 Trials studying Schizophrenia
652 Patients Enrolled for Schizophrenia
Ontario Shores Centre for Mental Health SciencesOTHER
12 Previous Clinical Trials
2,098 Total Patients Enrolled
3 Trials studying Schizophrenia
440 Patients Enrolled for Schizophrenia
Michael W Best, PhDPrincipal InvestigatorUniversity of Toronto
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Schizophrenia
60 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not been using drugs or drinking heavily in the past month.You are able to understand and communicate in English.You have a condition that causes seizures.You are able to operate a computer.You have participated in a brain-training program within the past 6 months.You have a neurological disease, a medical condition that affects your thinking abilities or a history of head injury with loss of consciousness.You have severe mental health symptoms that may worsen during the study and cause distress.You have a medical condition affecting your brain or have had a head injury that caused loss of consciousness.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Sham tDCs + ET
- Group 2: Actual tDCs + ET
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this research endeavor?
"The data on clinicaltrials.gov confirms that the research trial is actively seeking participants, beginning with its initial listing date of May 1st 2021 and latest update occurring October 31st 2022."
Answered by AI
Is enrollment available for this clinical research project?
"This research is accepting 40 participants with schizophrenia whose ages are between 18 and 65. The requisite criteria for enrolment includes: diagnosis of either schizophrenia, schizoaffective disorder or any other psychotic disorder according to the DSM-V manual, capability in English reading and speech comprehension, computer literacy, refraining from substance misuse over a month before applying."
Answered by AI
Does this medical study accept individuals aged 75 or older as participants?
"The parameters for this trial necessitate that enrolled patients are between 18 and 65 years old. Additionally, there exist 278 trials open to those younger than 18 and 750 studies available to individuals older than 65."
Answered by AI
How many individuals have agreed to partake in this experiment?
"Indeed, according to information published on clinicaltrials.gov, recruitment for this medical research is still in progress. Initially posted on the 1st of May 2021, the trial has since been modified as recently as 31 October 2022 and requires 40 participants from a single site."
Answered by AI
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