Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

Schizophrenia Clinical Trial

— MULTIMODHAL  

Official title:

Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373866
• Other study ID #: 2009_17/0927
• Secondary ID: 2009-A00842-55
• Status: Completed
• Phase: N/A
• Start date: November 15, 2010
• Est. completion date: February 11, 2022

Study information

• Verified date: December 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallucinations
• Perceptual Disorders
• Schizophrenia

Intervention

Device:
• MagPro X100 repetitive Transcranial Magnetic Stimulation
Target defined using both fMRI during hallucinations occurence and tractography. Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session
• MagPro X100 repetitive Transcranial Magnetic Stimulation
Target: T3-P3 (10-20 EEG international System). Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session

Locations

Country	Name	City	State
France	Lille University Hospital Centre	Lille
France	Saint-Anne Psychiatric Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity and Frequency of Hallucinations	Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)	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)
Secondary	Clinical State	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]	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)
Secondary	MRI changes	structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy	Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)