Actively Recruiting
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Led by Centre Hospitalier St Anne · Updated on 2024-07-29
20
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate. Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data, paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Broca's area, which would detect AVH in real time, and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them. The aim of this project is to assess the feasibility of this system. To do so, we will first test the ability of transcranial magnetic stimulation of the "continuous theta burst" (cTBS) type, applied at the time of AVH onset, to reduce their duration and intensity, and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction. Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system. The research project comprises two phases: -Phase 1: randomized controlled clinical trial (1 weekly session per patient over 12 weeks: 6 active stimulation sessions and 6 sham sessions) evaluating the phasic effects of rTMS on AVHs as they appear during the sessions. Phase 2: open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH (10 TMS sessions over one workweek - twice daily with 1-hour intervals, MULTIMODHAL study, NCT01373866).
CONDITIONS
Official Title
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years old
- Diagnosed with schizophrenic disorder according to DSM-5-TR
- Auditory-verbal hallucinations (AVHs) resistant to at least two antipsychotic treatments at effective doses for at least 8 weeks
- Experience frequent AVHs at least 10 times per hour
- Antipsychotic medication dosage unchanged for 30 days before joining the study
- AVHs are the main remaining symptom of schizophrenia
- Consent to participate in the study
You will not qualify if you...
- Pregnancy (confirmed by last menstrual period or urine test if uncertain)
- Taking anticonvulsant therapy
- Having neurological disorders like multiple sclerosis or epilepsy
- Current addictive behaviors except tobacco and cannabis
- Contraindications to MRI such as having ferromagnetic implants, cochlear implants, pacemakers, metal fragments, recent permanent makeup, or neurostimulation devices
- Exceeding weight of 130 kg or body size incompatible with MRI machine
- Not covered by social security
- Participating in another interventional research study or within the exclusion period of a previous study
- Refusal to be informed about brain anomalies found in MRI
- Under legal guardianship or curatorship
- Behavioral or delusional disorders that would prevent safe MRI or TMS procedures as judged by the investigator at baseline
AI-Screening
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Trial Site Locations
Total: 1 location
1
Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences
Paris, France
Actively Recruiting
Research Team
P
Philippe Domenech, MD, PhD
CONTACT
F
Fabien Vinckier, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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