Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDominique JANUEL
About this trial
This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient over 18 years of age
Patient diagnosed with schizophrenia according to DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
Patient agreeing to participate in the study and having signed an informed consent
Disqualifiers
Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
Presence of an unstabilized medical condition
Pregnant woman (Women of childbearing age without effective contraception)
Current or less than one month old engagement in another research protocol
Trial design
Design model
Parallel
Treatments tested in this trial
The rTMS method
Other interventionThe patient receives treatment under naturalistic conditions in routine practice.
The cTBS method
Other interventionThe patient receives the treatment under naturalistic conditions in routine practice.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: The rTMS methodOther 1 intervention
Group B: The cTBS methodOther 1 intervention
Trial outcomes
Primary outcomes
1
The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
Refer to the definition of AHRS above (in Primary Outcome Measure)
Time frame
Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatmentSecondary outcomes
1
Response rate: a response is defined as a decrease greater than or equal to 30% of total AHRS score from baseline to end of treatment.
Refer to the definition of AHRS above
Time frame
Baseline and at the end of the treatment2
Rate of patients with an end-of-treatment score < 3 on the Positive And Negative Syndrome Scale (PANSS) "Hallucinatory Behavior" item
The PANSS is a 30 items scale rated from 1 (absent) to 7 (extreme), that assesses psychopathological symptoms observed in patients with psychotic states, particularly schizophrenia.
Time frame
Baseline and at the end of the treatment3
Cognitive symptoms: Montreal Cognitive Assessment (MOCA), Stroop
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). It tends to replace the MMSE in clinical practice. 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).
Time frame
Baseline and 1 month after the end of treatment4
Addictive attitudes: number of cigarettes/d (tobacco), The Cannabis Abuse Screening Test (CAST), Marijuana Craving Questionnaire (MCQ)
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.
Time frame
Baseline and at the end of the treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dominique JANUEL
Lead sponsor
Centre hospitalier de Ville-Evrard, France
Sponsor institution
Source ClinicalTrials.gov