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NCT Number: NCT06595654

Treatment of Negative Symptoms of Schizophrenia by rTMS

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etablissement Public de Santé de Ville-Evrard

Neuilly-sur-Marne, 93330, France

Location status: Recruiting

Location contact

Dominique JANUEL, Pr.

PRINCIPAL_INVESTIGATOR

Noomane BOUAZIZ, Dr.

SUB_INVESTIGATOR

René BENADHIRA, Dr.

SUB_INVESTIGATOR

Rusheentira Thavaseelan

CONTACT

[email protected]

+33 1 43 09 32 32

Youcef Bencherif

CONTACT

[email protected]

+33 1 43 09 32 32

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation

Other
  • Patient is in a chair.
  • Hearing protection will be implemented.
  • The corresponding targeting method will be implemented.
  • The stimulation coil will be set up according to the indications of the targeting method.
  • A caregiver is present throughout the session.
  • After the session, the patient is re-assessed clinically for possible adverse effects.
  • If an adverse reaction is objectified, a doctor on site, is quickly mobilized.

Primary outcomes

  1. Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).

    Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)

    The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria:

    • Remission: 75%
    • Effective treatment: 50-74%
    • Improvement/response: 25-49%
    • No answer: <25%

Secondary outcomes

  1. Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.

    Time frame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.

    The PANSS (Positive and Negative Syndrome Scale) is composed of 3 parts: positive symptoms, negative symptoms and general psychopathology. The last part consists of 16 items. The score can range from 16 to 112. The CGI (Clinical Global Impression) is a 3-item scale: the severity of the disease, the overall improvement and the efficiency index. The first two items are scored from 0 to 7, and the last in a 4x4 table.

  2. Assess the impact of this treatment on response rate by the SANS

    Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)

    The Scale for the Assessment of Negative Symptoms (SANS) splits assessment into five domains (Affective flattening, Alogia, Avolition, Anhedonia, Attention). Within each domain it rates separate symptoms from 0 (absent) to 5 (severe). The response is defined by a 25-49% reduction in the initial score.

  3. Assess the impact of this treatment on the rate of remission by the number of remission with the SANS

    Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)

    The Scale for the Assessment of Negative Symptoms (SANS) splits assessment into five domains (Affective flattening, Alogia, Avolition, Anhedonia, Attention). Within each domain it rates separate symptoms from 0 (absent) to 5 (severe). Based on the percentage reduction of this score after 2-4 weeks, patients will be considered in remission if they have a 75% reduction..

  4. Assess the impact of this treatment on the relapse rate by the number of relapse with SANS

    Time frame: 4 weeks, 12 weeks and 24 weeks after the end of treatment.

    The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria:

    • Remission: 75%
    • Effective treatment: 50-74%
    • Improvement/response: 25-49%
    • No answer: <25%
  5. Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and STROOP

    Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)

    The MoCA scale is the most sensitive rapid assessment test and provides the broadest evaluation of cognitive functions (attention, concentration, executive functions, memory, language, visualconstructive abilities, abstraction, calculation, orientation). A score < 26 (25 if cultural level < 3 = primary diploma = CEP) is considered abnormal.

    The Stroop scale evaluates the capacity for attention and inhibition; thus, it allows to measure the level of interference generated by the automatisms in the accomplishment of a task. The result of the test allows us to see if the person is correctly inhibiting the response (values greater than 0, positive) or if there are significant interference problems (if it is a negative value).

  6. Assess the impact of this treatment on addictive attitudes by MCQ (Marijuana Craving Questionnaire) and CAST (Cannabis Abuse Screening Test)

    Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)

    The CAST is a 6-item scale for identifying problematic cannabis use. Each of these items describes use behaviors or problems encountered with cannabis use. The CAST score determines the patient's level of dependence. A score of 1 or less means low risk. A score of 2 means moderate risk. A score of 3 or higher means high risk. The MCQ self-report scale is a questionnaire on marijuana craving. It consists of four constructs or factors that characterize cannabis craving: compulsivity, emotionality, expectancy and determination. A separate score is calculated for each factor. The MCQ can be used to measure cue-induced craving in a research setting or natural craving in cannabis-dependent individuals presenting for treatment.

  7. Assess the impact of this treatment on mood by CDSS (Calgary Depression Scale for Schizophrenia).

    Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)

    The CDSS, is designed to assess depression in people with schizophrenia. . The questionnaire consists of 9 items covering the last 2 weeks. Each item is evaluated on a 4 points Likert scale ranging from : "Absent" (0) to "Severe" (3). The total score is obtained by adding the items and gives a score out of 27.

  8. Assess the impact of this treatment on quality of life by S-QoL-18

    Time frame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.

    The SQoL questionnaire is a self-administered quality of life scale that assesses quality of life in people with schizophrenia from the patient's perspective. The questionnaire has 18 items, each item is rated on a 4 points Likert scale ranging from: "Much less" to "More than desired". Scores range from 0 to 100; higher scores represent better quality of life.

  9. Assess the impact of this treatment on adverse reactions by the CGI

    Time frame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.

    The CGI (Clinical Global Impression) is a 3-item scale: the severity of the disease, the overall improvement and the efficiency index. The first two items are scored from 0 to 7, and the last in a 4x4 table. The last item allows a combined measurement of the main clinical effect and side effects.

Study contacts

Contact information is provided by the study sponsor or research team.

Youcef Bencherif

CONTACT

[email protected]

+33 1 43 09 32 32

Sponsors and collaborators

Lead sponsor

Centre hospitalier de Ville-Evrard, France

Other

Registry information

Official study title

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

Acronym: SN RENAT

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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