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Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation

Study acronym: HALLUSTIM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later May 2026 → Sep 2027
See other at-risk trials from Centre Hospitalier St Anne

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 2026 to Sep 2027 Show 4 more changesShow less
    • Trial status changed: Unknown → Recruiting
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Not Yet Recruiting to Unknown
    • Study sites: 0 to 1
    • Primary and study completion dates: Apr 2026 to May 2026
    • Start date changed from estimate of Apr 2024 to May 21, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06361160
Lead Sponsor Centre Hospitalier St Anne
Conditions
(from sponsor)		 Treatment Resistant Schizophrenia
Related terms Schizophrenia, Treatment-Resistant
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov