Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient over 18 years of age

• Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)

• Stable drug treatment for at least 4 weeks

• Presence or persistence of negative symptoms in the foreground:

⁃ Negative PANSS score ⩾21, positive PANSS score ⩽24

• Patient (or legal representative) willing to participate in the study and having signed an informed consent

• Patient fluent in the French language

• Affiliation to a social security scheme

Locations
Other Locations
France
Etablissement Public de Santé de Ville-Evrard
RECRUITING
Neuilly-sur-marne
Contact Information
Primary
Youcef Bencherif
urc@epsve.fr
+33 1 43 09 32 32
Time Frame
Start Date: 2023-06-09
Estimated Completion Date: 2028-03
Participants
Target number of participants: 124
Treatments
Other: Method 1
One stimulation session per day for 20 working days, so 4 weeks (frequency of 10 Hz, 80% 100% of motor threshold). Each session lasts 20 min. The duration of the train is 4 s, an inter-train of 56s.
Other: Method 2
Two stimulations sessions per day, with 1 hour apart, for 20 working days, so 4 weeks (frequency of 20 Hz, 100% of motor threshold).Each session lasts 28 min. The duration of the train of 10 s, an inter-train of 80s The total number of pulses is 40000 in 20 trains or 2000 per day.
Other: Method 3
Two stimulations session per day for 10 working days, so 2 weeks. The protocol is delivered in bursts containing 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., 5 Hz). Stimulation intensity is set at 80% of the idle motor threshold intensity
Other: Method 4
Five to ten sessions per day, 50 minutes apart, with 90% SM for 10 working days, so 2 weeks. 1 of stimuli every 20 ms (50Hz) repeated 3 times, this train itself repeated every 200 ms (5 Hz) or 60 cycles of 10 blocks of 3 stimuli. The duration of the train is 2 seconds with an inter-train of 8 seconds. So there are 1800 stimuli per session
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de Ville-Evrard, France

This content was sourced from clinicaltrials.gov