Treatment of Negative Symptoms of Schizophrenia by rTMS
NCT ID: NCT06595654
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2023-06-09
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Method 1
One stimulation session per day for 20 working days, so 4 weeks (frequency of 10 Hz, 80% 100% of motor threshold). Each session lasts 20 min. The duration of the train is 4 s, an inter-train of 56s.
repetitive Transcranial Magnetic Stimulation
* 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.
Method 2
Two stimulations sessions per day, with 1 hour apart, for 20 working days, so 4 weeks (frequency of 20 Hz, 100% of motor threshold).Each session lasts 28 min. The duration of the train of 10 s, an inter-train of 80s The total number of pulses is 40000 in 20 trains or 2000 per day.
repetitive Transcranial Magnetic Stimulation
* 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.
Method 3
Two stimulations session per day for 10 working days, so 2 weeks. The protocol is delivered in bursts containing 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., 5 Hz). Stimulation intensity is set at 80% of the idle motor threshold intensity
repetitive Transcranial Magnetic Stimulation
* 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.
Method 4
Five to ten sessions per day, 50 minutes apart, with 90% SM for 10 working days, so 2 weeks. 1 of stimuli every 20 ms (50Hz) repeated 3 times, this train itself repeated every 200 ms (5 Hz) or 60 cycles of 10 blocks of 3 stimuli. The duration of the train is 2 seconds with an inter-train of 8 seconds. So there are 1800 stimuli per session
repetitive Transcranial Magnetic Stimulation
* 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.
Interventions
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repetitive Transcranial Magnetic Stimulation
* 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of an unstabilized medical condition
* Pregnant woman
* Woman of childbearing potential and without effective contraception
* Breastfeeding woman
18 Years
ALL
No
Sponsors
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Centre hospitalier de Ville-Evrard, France
OTHER
Responsible Party
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Dominique JANUEL
Head of clinical research unit
Principal Investigators
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Dominique Januel
Role: PRINCIPAL_INVESTIGATOR
Clinical research unit, EPS Ville Evrard
Locations
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Etablissement Public de Santé de Ville-Evrard
Neuilly-sur-Marne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A02710-40
Identifier Type: -
Identifier Source: org_study_id
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