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?

The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time.

Participants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation.

We want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes

Participants will be asked to complete clinical interviews and questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment

This study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.

Who Is on the Research Team?

DB

David Benrimoh, MD.CM., MSc., MSc., FRCPC

Principal Investigator

McGill University, Department of Psychiatry

SP

Stéphane Potvin, PhD

Principal Investigator

Institut Universitaire en Santé Mentale de Montréal

LP

Lena Palaniyappan, MD, PhD

Principal Investigator

Douglas Mental Health Institute

OR

Olivier Roy, MD

Principal Investigator

Centre de recherche CERVO - Université Laval

Are You a Good Fit for This Trial?

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

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+