Neuromodulation Therapy for Schizophrenia
(TMSNS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new form of neuromodulation therapy to determine its effectiveness in improving symptoms like low motivation and difficulty in social interactions for people with schizophrenia. Participants will receive either the actual therapy or a placebo (sham) version, and the study will explore different application methods. The goal is to assess the treatment's safety and effectiveness over a short period. Individuals who have had schizophrenia for at least six months and experience significant negative symptoms might be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for schizophrenia.
Will I have to stop taking my current medications?
The trial requires that you have been on a stable medication plan for at least 4 weeks before joining, so you should not stop taking your current medications.
What prior data suggests that this neuromodulation therapy is safe for people with schizophrenia?
Research has shown that accelerated intermittent theta burst stimulation (iTBS) is generally safe and well-tolerated. In one study, people with schizophrenia showed improvements in their symptoms after receiving this treatment. Another study found that iTBS is a safe method with good potential for treating schizophrenia.
This treatment, which uses electrical or magnetic stimulation to influence brain function, shows promise as a safe and effective option. Specifically, another study noted high rates of improvement and recovery among participants, suggesting it is a safe choice. Overall, evidence indicates that accelerated iTBS is safe for people, with few side effects reported.12345Why are researchers excited about this trial?
Researchers are excited about accelerated neuromodulation therapy for schizophrenia because it offers a non-invasive approach to managing symptoms. Unlike standard treatments, which often involve antipsychotic medications with various side effects, this therapy uses intermittent Theta Burst Stimulation (iTBS) to target the brain's left dorsolateral prefrontal cortex. The therapy is unique in its use of advanced neuronavigation techniques, such as Neuronavigated Targeting and BEAM-F3 Targeting, to precisely deliver stimulation. This precision may enhance treatment effectiveness and reduce side effects, providing a promising alternative for patients seeking new options.
What evidence suggests that this accelerated neuromodulation therapy could be effective for schizophrenia?
Research has shown that accelerated neuromodulation therapy, using intermittent theta burst stimulation (iTBS), can reduce the negative symptoms of schizophrenia. In this trial, participants will receive different forms of iTBS targeting the left dorsolateral prefrontal cortex, which aids in decision-making and behavior. One group will receive neuronavigation-guided targeting, another will receive BEAM-F3 targeting, and a third group will receive sham iTBS as a comparator. Studies have found that iTBS can improve social skills and emotional expression. Participants in those studies reported fewer negative symptoms and better social interactions. iTBS is considered safe and may also enhance cognitive abilities like memory and attention. Overall, this treatment shows promise in helping people with schizophrenia.35678
Who Is on the Research Team?
Lena Palaniyappan, MD, PhD
Principal Investigator
Douglas Mental Health Institute
Olivier Roy, MD
Principal Investigator
Centre de recherche CERVO - Université Laval
Stéphane Potvin, PhD
Principal Investigator
Institut Universitaire en Santé Mentale de Montréal
David Benrimoh, MD.CM., MSc., MSc., FRCPC
Principal Investigator
McGill University, Department of Psychiatry
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder who have had significant negative symptoms and stable medication and symptom levels for at least 3 months. Participants must be able to get an MRI scan, give consent, and have been ill for at least 6 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive accelerated neuromodulation therapy or sham stimulation over five consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Accelerated Neuromodulation Therapy
Trial Overview
The study tests whether a fast neuromodulation therapy (using brain stimulation) can improve negative symptoms of schizophrenia compared to a placebo treatment. It also compares two ways of targeting the brain area for stimulation. Treatment lasts five days with follow-up visits.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using neuronavigation-guided targeting.
Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using BEAM-F3 targeting.
Participants receive sham iTBS over five consecutive days (ten sessions/day) using the same session structure and procedures as active treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Douglas Mental Health University Institute
Lead Sponsor
Centre de recherche CERVO
Collaborator
Magnus Medical
Industry Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborator
Citations
Effectiveness of accelerated intermittent theta burst ...
Conclusions: Accelerated iTBS can effectively ameliorate the social cognition and negative symptoms of individuals with schizophrenia. These results suggest ...
Efficacy and long-term effects of intermittent theta burst ...
Our meta-analysis suggests that iTBS may alleviate negative symptoms in schizophrenia, with preliminary evidence of long-term benefits observed ...
Effectiveness of accelerated intermittent theta burst ...
Accelerated iTBS can effectively ameliorate the social cognition and negative symptoms of individuals with schizophrenia. •. The Accelerated iTBS may be a safe ...
Accelerated Optimized Protocol of Intermittent Theta-Burst ...
Introduction: Intermittent theta burst stimulation (iTBS) has been associated with improvements in the negative symptoms (NSs) of schizophrenia.
5.
psychiatrist.com
psychiatrist.com/news/could-intermittent-theta-burst-stimulation-treat-schizophrenia/Could Intermittent Theta Burst Stimulation Treat ...
Intermittent theta burst stimulation (iTBS) over the left dorsolateral prefrontal cortex shows promise as a safe, effective schizophrenia treatment.
Efficacy and long-term effects of intermittent theta burst ... - PMC
Our meta-analysis suggests that iTBS may alleviate negative symptoms in schizophrenia, with preliminary evidence of long-term benefits observed ...
Accelerated Optimized Protocol of Intermittent Theta-Burst ...
Introduction: Intermittent theta burst stimulation (iTBS) has been associated with improvements in the negative symptoms (NSs) of schizophrenia.
Accelerated Neuromodulation Therapy for Negative ...
The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of ...
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