High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia : a Randomized Controlled Study (TMS-Hz)

July 28, 2015 updated by: University Hospital, Caen

Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) at High Frequency With Neuronavigation in the Treatment of Auditory Hallucinations : A Randomized Multicentric Controlled Study

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 patients presented a drastic improvement with no hallucinations after 12 days of rTMS. The investigators also showed the target based on anatomical and functional MRI was located at the intersection of the left STS and the coronal slice across the vertical line of sylvius sulcus.

The aim of this multicentric double-blind study (randomized and placebo sham) is to demonstrate the efficacy of rTMS at high frequency with neuronavigation in the treatment of auditory hallucinations in patients with schizophrenia and schizo-affective disorders (DSMIV-R).

Methods:

72 subjects will be included after written consent. After randomization, the subject will receive in a double blind either active treatment or placebo (sham coil) treatment.

rTMS : 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered. These parameters allow the investigators to be under the risk of epilepsia, the only one severe side effect. Another mild side effect is headache easily treated by antalgic drugs. The target will be established with anatomical MRI eventually associated with functional MRI before treatment.

The efficacy of treatment will be evaluated over 4 weeks (D0, D1, D2, D7, D14, D21 and D30). The primary assessment is the percentage of patients who present a decrease of more than 30% of the frequency item of Auditory Hallucinations Rating Scale (AHRS) between D1 and D30 at 2 evaluations spaced of 1 week (Responder patients). The secondary assessments are : 1- Relative decrease of frequency item of AHRS between D1 and D14 ; 2- Evolution of total score of AHRS at D1, D2, D7, D14, D21 and D30 ; 3- Variation of scores of CGI, SUMD, IS, positive, negative, general and total PANSS scores between D0 and D14 and D30 ; 4- Scores at secondary side effects (adapted UKU) at D2 and D7; 5- Distances between the present target and the classical target based on 10-20 EEG system (T3P3) and/or the target established with functional MRI (cluster of activations induced by a listening comprehension task).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • CAEN University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with schizophrenic disorders aged from 16 to 65 years old
  • Patients suffering from auditory hallucinations (score AHRS > 10) undergoing antipsychotic treatments
  • patients clinically stabilised (no antipsychotic treatments modifications for the last 2 months
  • Written signed consent

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • patients with a brain tumor
  • Patients with previous history of epilepsy
  • Patients already treated once by rTMS
  • Counter-indication to MRI or to rTMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial magnetic stimulation: rTMS
rTMS : 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered
Device: Transcranial magnetic stimulation: rTMS
4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered
Placebo Comparator: placebo (sham coil) treatment
Device: Placebo (sham coil) treatment
Sham coil treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Sonia Dollfus, MD, PhD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 26, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A01589-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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