Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

Not Applicable

Completed

• Conditions: Hallucinations; Perceptual Disorders; Schizophrenia

• Registration Number: NCT01373866
• Lead Sponsor: University Hospital, Lille

Brief Summary

* The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)

* This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations

* The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-15
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Primary Completion: 2022-02-11
• Study Completion: 2022-02-11
• Status Verified: 2023-12
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Right-handed Female/Male, [13-60 y.o.],
• Schizophrenia (DSM-IV-TR diagnosis),
• Drug-resistant hallucinations (Kinon & Kane criteria, 1993),
• Unmodified antipsychotic dosage during the 30 days preceding rMTS,
• No anticonvulsive medication,
• No neurological disorder, no addictive behavior,
• Matched for sex, age and PANSS scores,
• Consent to participate to the study,

Exclusion Criteria

• Pregnancy
• Contraindication to MRI scan
• Contraindication to rTMS treatment
• Claustrophobia
• No social insurance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity and Frequency of Hallucinations	Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)	Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)

Secondary Outcome Measures

Name	Time	Method
MRI changes	Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)	structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy
Clinical State	Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)	Clinical Global Improvement \[CGI\]/ Positive \& Negative Symptoms Scale \[PANSS\]/ Global Assessment of Functioning \[GAF\].; For the auditory modality: Add the Auditory Hallucinations rating Scale \[AHRS\] frequency scale and total score/ Add the computerized Binary Scale of Auditory Speech Hallucinations \[cbSASH\]

Trial Locations

Locations (2)

Lille University Hospital Centre; 🇫🇷 Lille, France

Saint-Anne Psychiatric Hospital; 🇫🇷 Paris, France