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ID06595654

Study of Repetitive Transcranial Magnetic Stimulation to Treat Negative Symptoms in Adults with Schizophrenia

Led by Centre hospitalier de Ville-Evrard, France · Updated on 2024-09-19

124

Participants Needed

1

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of repetitive Transcranial Magnetic Stimulation rTMS on the negative symptoms of schizophrenia in real-world conditions. This study aims to provide a regulatory framework for rTMS treatments by comparing four different rTMS protocols adapted to patients tolerances. The treatment duration ranges from 2 to 4 weeks, followed by a 3-month follow-up period to observe relapses. The main measurement used to assess changes in negative symptoms is the Scale for the Assessment of Negative Symptoms SANS. Participants receive one of four different rTMS protocols. These include daily sessions for 20 working days or twice daily sessions for 10 or 20 working days, with varying frequencies and stimulation intensities. Each session lasts between 20 and 50 minutes, involving specific patterns of magnetic pulses and intervals. Patients sit in a chair with hearing protection during treatment, and a caregiver is present throughout each session. After treatment, patients are clinically reassessed for potential side effects. During the study, participants undergo clinical assessments using several scales including SANS, PANSS, CGI, MOCA, STROOP, MCQ, CAST, CDSS, and S-QoL-18 to evaluate symptom changes, cognitive function, mood, addictive behaviors, quality of life, and adverse reactions. These evaluations occur at baseline, end of treatment, and multiple follow-up points up to 24 weeks post-treatment. Safety is monitored closely, with a doctor available if adverse reactions occur. Total participation spans the treatment period plus up to 24 weeks of follow-up.

CONDITIONS

Brief Title

Treatment of Negative Symptoms of Schizophrenia by rTMS

Research Team

Y

Youcef Bencherif

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