Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia
rTMS
2 other identifiers
interventional
33
1 country
1
Brief Summary
Auditory Hallucinations (AH) are experienced by 50 to 70% of subjects with schizophrenia. Almost a quarter of patients are medication resistant to such symptoms. The application of rTMS at low frequency in the left temporoparietal cortex reduces AH. A pilot study reported successful treatment of AH with high frequency rTMS. rTMS (20Hz) should be a shorter and an easier treatment for out-patients with schizophrenia compared to low stimulation treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Feb 2014
Typical duration for not_applicable schizophrenia
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
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
June 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2017
CompletedSeptember 8, 2023
September 1, 2023
3.4 years
May 22, 2014
September 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficiency of high frequency (20Hz) repetitive Transcranial Magnetic Stimulation (rTMS) to the left temporoparietal cortex compared to sham controlled condition rTMS in term on Auditory Hallucinations reduction.
Auditory Hallucinations improvement at 5-day was evaluate with AHRS (Auditory Hallucination Rating Scale) score
5 day
Secondary Outcomes (5)
To compare the efficiency of low frequency (1Hz) to sham-controlled condition repetitive Transcranial Magnetic Stimulation (rTMS) in term of Auditory Hallucination reduction.
5 days
To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.
5 days
To compare the maintenance of therapeutic effect for one month of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.
1 month
To evaluate the maintenance of therapeutic effect of high frequency compared to sham controlled condition for 15 days 1 month, 2 months and 3 months
15 days 1 month, 2 months and 3 months
To compare the side effects of each of the active treatment
at Inclusion and 5 day
Study Arms (3)
low frequency (1Hz)
ACTIVE COMPARATORlow frequency
Sham Comparator
SHAM COMPARATORSham Comparator
high frequency (20Hz)
EXPERIMENTALhigh frequency
Interventions
Eligibility Criteria
You may qualify if:
- Patients with schizophrenia DSM IV-TR criteria and persistent AH resistant to antipsychotic treatments.
You may not qualify if:
- Left handed patients lateralizes
- rTMS contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, Louis Mourier Hospital
Colombes, 92700, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Caroline DUBERTRET, PU-PH
Department of Psychiatry, Louis MOURIER Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2014
First Posted
June 26, 2014
Study Start
February 1, 2014
Primary Completion
July 7, 2017
Study Completion
September 29, 2017
Last Updated
September 8, 2023
Record last verified: 2023-09