Clinical Trial: High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia : a Randomized Controlled Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) at High Frequency With Neuronavigation in the Treatment of Auditory Hallucinations : A Randomized Multice

Brief Summary:

Background:

Repetitive transcranial magnetic stimulation (rTMS) is a recent therapeutic which has demonstrated its efficacy in the treatment of auditory hallucinations in patients with schizophrenic disorders. Up to now, the target of stimulation has been over the left temporoparietal region (based on the international 10-20 EEG system) and rTMS has been delivered at low frequency (1 Hz).

High frequency (20 Hz) might allow shortening the duration of treatment and so could be more convenient for the patient (2 days at high frequency instead of 15 days at low frequency).

Besides high frequency, an accurate target taking into account the inter-subjects anatomical variability might increase the efficacy. Based on a great overlap of language and auditory hallucinations networks, the investigators hypothesized that targeting the stimulation on the highest cluster of activation induced by a language task could be an easier and relevant method to determine the target. The investigators suggest that the best area is located at the posterior part of the left superior temporal sulcus (STS). Indeed, this area is considered as an " epicenter " of language, i.e., involved both in understanding and production of language and in the auditory hallucination network. Therefore, the investigators conducted an open pilot study in order to test the interest of rTMS at high frequency (20 Hz) associated with anatomical and functional magnetic resonance imaging (MRI) and neuronavigation in 11 schizophrenic patients with hallucinations. The investigators showed a significant reduction of auditory hallucinations; Seven out of 11 patients (63.8%) were considered as responders at day 12 with a decrease of more than 30% of the score of Hoffman's scale (Auditory Hallucinations Rating Scale) ; 2

Detailed Summary:
Sponsor: University Hospital, Caen

Current Primary Outcome: The primary assessment is the percentage of patients who present a decrease of more than 30% of the frequency item of AHRS between D1 and D30 at 2 evaluations spaced of 1 week (Responder patients) [ Time Frame: Day 30 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Caen

Dates:
Date Received: November 26, 2009
Date Started: August 2009
Date Completion:
Last Updated: July 28, 2015
Last Verified: July 2015