Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations (TMS HALLU)
Primary Purpose
Schizophrenic Disorders
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Transcranial magnetic stimulation: rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenic Disorders focused on measuring Schizophrenia, auditory hallucinations, TMS
Eligibility Criteria
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
Sites / Locations
- Caen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcranial magnetic stimulation: rTMS
Arm Description
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
Outcomes
Primary Outcome Measures
HOFFMAN score
Secondary Outcome Measures
Full Information
NCT ID
NCT02525315
First Posted
August 13, 2015
Last Updated
August 14, 2015
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT02525315
Brief Title
Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations
Acronym
TMS HALLU
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenic Disorders
Keywords
Schizophrenia, auditory hallucinations, TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial magnetic stimulation: rTMS
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation: rTMS
Intervention Description
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
Primary Outcome Measure Information:
Title
HOFFMAN score
Time Frame
change between baseline and day 3 or day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Dollfus, MD, PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
12. IPD Sharing Statement
Learn more about this trial
Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations
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