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Behavioural Intervention
Theta Burst Stimulation for Schizophrenia (REDOCS Trial)
N/A
Recruiting
Led By Fabio Ferrarelli, MD, PhD
Research Sponsored by Fabio Ferrarelli
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DSM diagnoses of Schizophrenia Spectrum Axis I disorders
Ages 18-40 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre itbs), within one hour from itbs
Awards & highlights
REDOCS Trial Summary
This trial will use transcranial magnetic stimulation (TMS) to study the effects of iTBS on the natural oscillatory frequency of the dorsolateral prefrontal cortex (DLPFC) and working memory in early-course schizophrenia patients.
Who is the study for?
This trial is for individuals aged 18-40 with early-course schizophrenia, having experienced psychosis for less than three years. Participants must have a diagnosis within the Schizophrenia Spectrum and be able to give informed consent. It's not open to those who are pregnant or recently postpartum, have diabetes with certain complications, significant neurological disorders, substance dependence (except cannabis/alcohol), or a history of severe head injury.Check my eligibility
What is being tested?
The study tests if Theta Burst Stimulation (iTBS) can improve brain function and memory in people with early schizophrenia. iTBS uses magnetic pulses on the brain while EEG tracks activity changes. Participants will receive either real iTBS or a sham treatment without active stimulation to compare effects on working memory.See study design
What are the potential side effects?
While iTBS is generally considered safe, potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or temporary hearing issues due to the noise during treatment. Rarely it could cause seizures but this is closely monitored.
REDOCS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a schizophrenia spectrum disorder.
Select...
I am between 18 and 40 years old.
REDOCS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre itbs), within one hour from itbs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre itbs), within one hour from itbs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in AX-Continuous Performance Task Error Rate (AX-CPT ER) following iTBS
Change in AX-Continuous Performance Task Reaction Time (AX-CPT RT) following iTBS
Change in AX-Continuous Performance Task d' context (AX-CPT d') following iTBS
+3 moreREDOCS Trial Design
2Treatment groups
Experimental Treatment
Group I: sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFCExperimental Treatment2 Interventions
This arm will first receive sham iTBS (i.e., with the TMS coil in the placebo orientation) and then active iTBS stimulation over the left dorsolateral prefrontal cortex (DLPFC).
Group II: active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFCExperimental Treatment2 Interventions
This arm will first receive active iTBS stimulation and then sham iTBS over the left dorsolateral prefrontal cortex (DLPFC).
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,202 Total Patients Enrolled
248 Trials studying Schizophrenia
89,349 Patients Enrolled for Schizophrenia
Fabio FerrarelliLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Schizophrenia
200 Patients Enrolled for Schizophrenia
Fabio Ferrarelli, MD, PhDPrincipal InvestigatorUniversity of Pittsbrugh
3 Previous Clinical Trials
165 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a schizophrenia spectrum disorder.I am between 18 and 40 years old.I have a medical condition that affects my brain.I have undergone electroconvulsive therapy.I or someone in my family has epilepsy.I have diabetes with seizures, limb issues, or brief losses of consciousness.I had a concussion where I was unconscious for more than 10 minutes.I have a serious neurological condition, like epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFC
- Group 2: sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFC
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.
How many participants are currently undergoing this clinical research?
"Indeed, the information publicised on clinicaltrials.gov corroborates that this clinical trail is currently searching for subjects. It was first announced on November 5th 2021 and has been revised most recently on December 4th 2021, with 75 patients required to be recruited from 1 medical centre."
Answered by AI
Is recruitment currently underway for this experiment?
"Affirmative. The clinical trial details published on clinicaltrials.gov suggest that recruitment is currently in progress, with the initial posting dated November 5th 2021 and the last update occurring December 4th 2021. This medical research is looking for 75 individuals to participate from a single site."
Answered by AI
Does this trial offer inclusion to those younger than fifty years of age?
"The minimum age for entry into this trial is 18, and the maximum limit has been set at 40 years old."
Answered by AI
Who meets the criteria to take part in this medical trial?
"This trial requires 75 participants with schizophrenia aged between 18 and 40 to be recruited. To qualify for the study, individuals must have had symptoms or been in treatment for a period of less than three years according to clinical guidelines from UPMC psychoses clinics located in Pittsburgh."
Answered by AI
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