Schizophrenia Patients With First Rank Symptoms Clinical Trial
— SchirangOfficial title:
Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of First Rank Symptoms on Schizophrenia: Controlled, Randomised, Double Blind Trial
Verified date | September 2023 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
First rank symptoms are core symptoms of schizophrenia. the investigators want to offer an integrative approach to better understanding of the mechanisms involved in the first rank symptoms and therefore, in schizophrenia, as well as the neuronal modulation mechanisms obtained by rTMS. It will be to pass a functional magnetic resonance imaging (fMRI) at rest for healthy volunteers, and for patients before and after rTMS modulation, to view brain structures activated in the resting state network, and in order to study 1. the difference of the resting-state network between healthy volunteers and people with schizophrenia, 2. if the response to rTMS boost can be predicted by resting-state network of patients before treatment and 3. if rTMS changes activations in the brain of patients. This will ultimately provide rTMS as a treatment of first rank symptoms.
Status | Completed |
Enrollment | 31 |
Est. completion date | March 3, 2023 |
Est. primary completion date | March 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Suffering from schizophrenia (according to DSM IV-TR) - Presenting FRS at least once a day despite well-conducted antipsychotic treatment, objectified by FRS subscore of the SAPS (items 2, 3 and items 15-19) with at least two FRS listed > 1 of the corresponding item of the SAPS - Being informed of the objectives and constraints of the study and signing the consent form or signing by the guardian - Patient having had a preliminary clinical examination Exclusion Criteria: - Left-lateralized - Previously treated with rTMS in the previous 6 month, - Contraindications of the rTMS practice: unstabilized epilepsy, presence of foreign eye metallic material, pacemaker, neurostimulator, cochlear implants and in general all medical equipment installed immovably, metal heart valve, vascular clips formerly located on cranial aneurysm - Pregnancy or breastfeeding women - hospitalization under constraint - Subject already involved in another interventional clinical research evaluating schizophrenia treatment - patient with severe drug use disorder (excluding coffee and tobacco) according to the DSM-5 criteria |
Country | Name | City | State |
---|---|---|---|
France | Louis Mourier | Colombes |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of first rank symptoms | Number of first rank symptoms measured by items 2,3 and 15 to 19 of "first rank" subscore from SAPS | 5 days after inclusion | |
Secondary | Evaluation of both agency and sense of body ownership disorders with Rubber Hand Illusion test (RHI) | RHI Test is composite evaluation . A wooden hand will be placed in front of the subject while his proper hand rests, hidden from his vision. When applying identical and synchronous active movement to both the wooden and the subject hidden hand, subject feels rapidly as moving directly to the rubber hand level, and develops a sense of ownership to this artificial hand. The intensity of the illusion is measured subjectively by answering a questionnaire (over sense of one's own body and agency). The intensity of the illusion is measured objectively by measuring proprioceptive bias in millimeters after each stimulation by asking the subject to place his own hand after illusion induction. |
5 days, 1 month and 3 months after inclusion | |
Secondary | Evaluation of familiarity disorder | Face morphing tasks have been used for a decade to identify facial recognition defects and allow calculating a recognition threshold (percentage of the faces morphed required for recognition). This threshold may be compared over time. Faces are morphed between the subject's face with same sex pictures either familiar (2 persons close to the patient) or unfamiliar (two faces from a database34). The subjects indicate when they recognize their relative or when a stranger emerges during computer presentation of morphed images, to a varying extent from 0 to 100% (by 10% step). A threshold of recognition per conditions (self, familiar, unknown) will be extract for each subject as a percentage | 5 days, 1 and 3 month after inclusion | |
Secondary | Evaluation of the severity of symptoms | use of the Positive And Negative Symptoms Scale PANSS, an hetero evaluation of schizophrenia symptoms | 5 days, 1 and 3 month after inclusion | |
Secondary | Evaluation of the functioning | By using the Global Assessment of Functioning (GAF) | 5 days, 1 and 3 month after inclusion | |
Secondary | Evaluation of quality of life | By using the Shortened Quality of Life Questionnaire (S-QoL 18) | 5 days, 1 and 3 month after inclusion | |
Secondary | Evaluation of the side effects | By using the Side effects surveillance (UKU) | 5 days after inclusion |