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Repetitive Transcranial Magnetic Stimulation for "Voices"

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00004980
First received: March 10, 2000
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
Results First Received: November 25, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Device: repetitive transcranial magnetic stimulation (rTMS)
Device: sham stimulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Repetitive Transcanial Magnetic Stimulation Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo Participants received sham stimulation

Participant Flow:   Overall Study
    Active Repetitive Transcanial Magnetic Stimulation     Placebo  
STARTED     27     23  
COMPLETED     25     21  
NOT COMPLETED     2     2  
Withdrawal by Subject                 1                 0  
memory difficulties                 1                 1  
Physician Decision                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Active Repetitive Transcanial Magnetic Stimulation Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo Participants received sham stimulation
Total Total of all reporting groups

Baseline Measures
    Active Repetitive Transcanial Magnetic Stimulation     Placebo     Total  
Number of Participants  
[units: participants]
 		  27     23     50  
Age  
[units: Years]
Mean ± Standard Deviation 		  35.1  ± 11.9     35.5  ± 9.5     35.3  ± 10.8  
Gender  
[units: participants]
 		     
Female     9     8     17  
Male     18     15     33  
Medication Resistance [1]
[units: Participants]
 		     
Medication Resistant     21     18     39  
Not Medication Resistant     6     5     11  
Total Auditory Hallucination Rate Scale (AHRS) score [2]
[units: Scores on a scale]
Mean ± Standard Deviation 		  25.1  ± 5.0     26.1  ± 5.7     25.6  ± 5.3  
[1] Number of participants who were medication resistant
[2] Sum of 7 variables: frequency of hallucinations, reality of hallucinations, loudness of hallucinations, number of acoustically distinct voices, length of hallucinations, attentional salience of hallucinations, level of distress induced by hallucinations; higher score connotes more severe hallucinations; lowest score is 4, highest score is 37



  Outcome Measures
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1.  Primary:   Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions   [ Time Frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) ]
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2.  Secondary:   Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions   [ Time Frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) ]
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3.  Secondary:   Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions   [ Time Frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) ]
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4.  Secondary:   Responder Status   [ Time Frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Ralph Hoffman
Organization: Yale University School of Medicine
phone: 203-688-9734
e-mail: ralph.hoffman@yale.edu


Publications of Results:


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00004980     History of Changes
Other Study ID Numbers: R21 MH063326, R21MH063326, YALESM-9281, 199/14809, A5-ETPD
Study First Received: March 10, 2000
Results First Received: November 25, 2008
Last Updated: June 5, 2012
Health Authority: United States: Federal Government