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Repetitive Transcranial Magnetic Stimulation for "Voices"

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
sham stimulation
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring neurologic and psychiatric disorders, rare disease, schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active rTMS

sham stimulation

Arm Description

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)

Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)

Outcomes

Primary Outcome Measures

Hallucination Change Score (HCS) After 9 Active/Sham 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

Secondary Outcome Measures

Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
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
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
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

Full Information

First Posted
March 10, 2000
Last Updated
August 5, 2013
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00004980
Brief Title
Repetitive Transcranial Magnetic Stimulation for "Voices"
Official Title
Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
neurologic and psychiatric disorders, rare disease, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active rTMS
Arm Type
Experimental
Arm Description
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)
Arm Title
sham stimulation
Arm Type
Placebo Comparator
Arm Description
Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS)
Other Intervention Name(s)
MATSTIM SUPER RAPID
Intervention Description
a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
Intervention Type
Device
Intervention Name(s)
sham stimulation
Other Intervention Name(s)
MAGSTIM SUPER RAPID
Intervention Description
132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
Primary Outcome Measure Information:
Title
Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
Description
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
Time Frame
After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Secondary Outcome Measure Information:
Title
Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
Description
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.
Time Frame
After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Title
Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions
Description
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
Time Frame
After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Title
Responder Status
Description
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
Time Frame
After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Hoffman
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8099
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15936729
Citation
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. doi: 10.1016/j.biopsych.2005.03.041.
Results Reference
result
Links:
URL
http://psychiatry.yale.edu/research/programs/clinical_people/rtms.aspx
Description
Click here for the Yale School of Medicine Web site describing current, on-going rTMS trial for auditory hallucinations

Learn more about this trial

Repetitive Transcranial Magnetic Stimulation for "Voices"

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