Repetitive Transcranial Magnetic Stimulation for "Voices"

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00004980
First received: March 10, 2000
Last updated: August 5, 2013
Last verified: August 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Ralph Hoffman Yale University
  More Information

Additional Information:
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: August 5, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 29, 2014