Treatment of Negative Symptoms of Schizophrenia by rTMS (SN RENAT)

Centre hospitalier de Ville-Evrard, France

Status: Enrolling

Conditions: Negative Symptoms in Schizophrenia; Schizophrenia

Treatments: Other: repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06595654

2021-A02710-40

Details and patient eligibility

About

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).

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
• Presence of an unstabilized medical condition
• Pregnant woman
• Woman of childbearing potential and without effective contraception
• Breastfeeding woman

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 4 patient groups

Method 1

Other group

Description:

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.

Treatment:

Other: repetitive Transcranial Magnetic Stimulation

Method 2

Other group

Description:

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.

Treatment:

Other: repetitive Transcranial Magnetic Stimulation

Method 3

Other group

Description:

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

Treatment:

Other: repetitive Transcranial Magnetic Stimulation

Method 4

Other group

Description:

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

Treatment:

Other: repetitive Transcranial Magnetic Stimulation