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Completed

NCT Number: NCT00004980

Repetitive Transcranial Magnetic Stimulation for "Voices"

OBJECTIVES:

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

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Key information

Conditions

Schizophrenia Disease Attributes Mental Disorders Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520-8099, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site

Other names: MATSTIM SUPER RAPID

Sham stimulation

Device

132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site

Other names: MAGSTIM SUPER RAPID

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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

  3. Responder Status

    Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

    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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2005
Study completion
2005
First posted
Mar 13, 2000
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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