Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations (TMS HALLU)

August 14, 2015 updated by: University Hospital, Caen

Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating. Behavioral disorders associated with them can have serious social repercussions. However, in 25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.

Fifteen subjects will be included after collection and signed their informed consent.

The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay below the risk of occurrence of seizures, the only serious side effects identified. Furthermore the rTMS treatment is almost painless: tension headaches are the main side effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The LEFT stimulation site will be established through a anatomofunctional imaging before treatment (between D-7 and D0).

Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the first 2 weeks of starting treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with schizophrenic disorders aged from 18 to 60 years old
  • Patients suffering from auditory hallucinations undergoing antipsychotic treatments
  • Written signed consent

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HOFFMAN score
Time Frame: change between baseline and day 3 or day 12
change between baseline and day 3 or day 12

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

June 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-137

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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