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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
  Purpose

OBJECTIVES:

I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
 Device: repetitive transcranial magnetic stimulation (rTMS)
Device: sham stimulation
 Phase 2

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
Official Title: Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.

  • 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) ] [ Designated as safety issue: No ]
    Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened

  • Responder Status [ Time Frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) ] [ Designated as safety issue: No ]

    Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions.

    Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline



Enrollment: 50
Study Start Date: December 1999
Study Completion Date: June 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active rTMS
1-Hz rTMS delivered to left temporoparietal cortex at 90% motor threshold for 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)
 Device: repetitive transcranial magnetic stimulation (rTMS)
a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
Other Name: MATSTIM SUPER RAPID
Placebo Comparator: sham stimulation
Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)
 Device: sham stimulation
132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
Other Name: MAGSTIM SUPER RAPID

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of two treatment arms.

Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends.

Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. The total duration of sham stimulation is 132 minutes. Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends.

This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

Inclusion criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
  • Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
  • Right-handed
  • At least 4 weeks on stable antipsychotic medication

Exclusion criteria:

  • history of seizure (unless due to drug withdrawal or medication that is no longer prescribed)
  • history of epilepsy in first degree relatives
  • estimated IQ less than 80
  • unable to provide informed consent
  • significant unstable medical condition
  • current treatment with clozapine or bupropion
  • cochlear implants or other metal in the head (surgical, etc.)
  • history of cardiac arrhythmia
  • cardiac pacemaker
  • active drug or alcohol abuse within prior 6 weeks
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004980

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8099
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Ralph Hoffman Yale University
  More Information

Additional Information:
Click here for the Yale School of Medicine Web site describing current, on-going rTMS trial for auditory hallucinations  This link exits the ClinicalTrials.gov site

Publications:

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

Keywords provided by Yale University:
neurologic and psychiatric disorders
rare disease
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013