Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations
TMS HALLU
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 17, 2015
CompletedAugust 17, 2015
August 1, 2015
5 years
August 13, 2015
August 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HOFFMAN score
change between baseline and day 3 or day 12
Study Arms (1)
Transcranial magnetic stimulation: rTMS
EXPERIMENTALrTMS : 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients with schizophrenic disorders aged from 18 to 60 years old
- Patients suffering from auditory hallucinations undergoing antipsychotic treatments
- Written signed consent
You may not qualify if:
- Pregnancy or breastfeeding
- Counter-indication to MRI or to rTMS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caen University Hospital
Caen, 14033, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonia Dollfus, MD, PhD
University Hospital, Caen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2015
First Posted
August 17, 2015
Study Start
June 1, 2007
Primary Completion
June 1, 2012
Study Completion
December 1, 2013
Last Updated
August 17, 2015
Record last verified: 2015-08