Stratifying Psychoses for Personalized REpetitive TMS in Persistent NEgative Symptoms Alleviation

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with schizophrenia, particularly those experiencing persistent negative symptoms (PNS), such as a lack of motivation, social withdrawal, or emotional flatness. Researchers want to see if a specific type of brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can help improve these symptoms more effectively when tailored to individual patients. The trial will focus on people with a rare condition known as progressive periodic catatonia (PPC), which has distinct symptoms and may respond better to a personalized approach compared to other types of schizophrenia.

To be eligible for the trial, participants should be between 18 and 70 years old, speak French at a certain level, and have been diagnosed with schizophrenia along with persistent negative symptoms for at least six months. They should also be on a stable medication plan. Participants will receive information about the study and will need to sign consent before joining. Throughout the trial, they can expect to undergo brain stimulation treatments and be monitored for improvements in their symptoms. This study aims to find more effective ways to help those struggling with these challenging aspects of schizophrenia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-70 years of age; affiliated to health insurance; superior or equal to B2 level of linguistic competency in French.
• • Suffering from schizophrenia spectrum disorder (SSD) in residual state with persistent negative symptoms (PNS): (1) SSD: ICD-11 codes beginning with 6A2 + primary catatonia (codes beginning with 6A4) + simple schizophrenia as defined in ICD-10 (F20.6); (2) PNS: persistence (≥6 months - based on patient ± informant's interview) of ≥2 negative symptoms (PANSS-N1, N2, N3, N4, N6 ≥4) with functional impact.
• • Half of subjects having PPC, the other half suffering from another phenotype or nPPC (neuropsychiatric procedure or probabilistic, i.e. Bayes-PPC).
• • Under a stable medication regimen for \>6 weeks,
• • Subjects who have received the protocol information and signed informed consent.
• Exclusion Criteria:
• • - Contraindications for MRI or rTMS.
• • Motor deficit at neurological examination.
• • Secondary negative symptoms: (1) withdrawal secondary to severe anxiety (especially due to positive symptoms), (2) depression, (3) maintenance on high dose antipsychotics, (4) extra-pyramidal or (5) sedation side-effects, (6) treatment non-compliance, (7) current substance abuse (except nicotine and caffeine), (8) unsubstituted past opioid addiction, (9) poor health or social condition.
• • Under antiepileptic drugs (except lamotrigine and long-term use of benzodiazepines).
• • Pregnancy; severe medical condition; care under constraint.