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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

March 10, 2000
August 5, 2013
December 1999
January 2005   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00004980 on ClinicalTrials.gov Archive Site
  • 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

Not Provided
Not Provided
Not Provided
 
Repetitive Transcranial Magnetic Stimulation for "Voices"
Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"

OBJECTIVES:

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • 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
  • 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)
    Intervention: Device: repetitive transcranial magnetic stimulation (rTMS)
  • 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)
    Intervention: Device: sham stimulation
Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, Carroll K, Krystal JH. Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 2005 Jul 15;58(2):97-104.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004980
R21 MH063326, R21MH063326, YALESM-9281, 199/14809, A5-ETPD
Yes
Yale University
Yale University
National Institute of Mental Health (NIMH)
Study Chair: Ralph Hoffman Yale University
Yale University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP