Clinical Trial: Multimodal MRI-guided rTMS to Treat Refractory Hallucinations

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University Hospital, Lille

Current Primary Outcome: Severity and Frequency of Hallucinations [ Time Frame: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical State [ Time Frame: 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]

  • MRI changes [ Time Frame: Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1) ]
    structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: May 13, 2011
Date Started: November 15, 2010
Date Completion: November 2017
Last Updated: May 17, 2017
Last Verified: May 2017