75 Participants NeededMy employer runs this trial

Neuromodulation Therapy for Schizophrenia

(TMSNS Trial)

Recruiting at 2 trial locations
AS
Overseen ByAshley S. Choucroun
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Douglas Mental Health University Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

LP

Lena Palaniyappan, MD, PhD

Principal Investigator

Douglas Mental Health Institute

OR

Olivier Roy, MD

Principal Investigator

Centre de recherche CERVO - Université Laval

SP

Stéphane Potvin, PhD

Principal Investigator

Institut Universitaire en Santé Mentale de Montréal

DB

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

I have noticeable negative symptoms that affect my daily life.
* Ability to undergo MRI scanning
* Must have been on a stable pharmacological treatment for at least 4 weeks before entering the study
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated neuromodulation therapy or sham stimulation over five consecutive days

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
3 visits (in-person)

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

Group I: Active iTBS (Neuronavigated Targeting)Experimental Treatment1 Intervention
Group II: Active iTBS (BEAM-F3 Targeting)Experimental Treatment1 Intervention
Group III: Sham iTBSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Douglas Mental Health University Institute

Lead Sponsor

Trials
31
Recruited
2,800+

Centre de recherche CERVO

Collaborator

Trials
1
Recruited
5,000+

Magnus Medical

Industry Sponsor

Trials
5
Recruited
1,100+

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Collaborator

Trials
13
Recruited
1,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36603383/

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41008381/

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.

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 ...