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Clinical Trials/NCT02525315
NCT02525315
Completed
Phase 2

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

University Hospital, Caen1 site in 1 country15 target enrollmentJune 2007

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Schizophrenic Disorders
Sponsor
University Hospital, Caen
Enrollment
15
Locations
1
Primary Endpoint
HOFFMAN score
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

HOFFMAN score

Time Frame: change between baseline and day 3 or day 12

Study Sites (1)

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