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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH063326 | U.S. NIH Grant/Contract | View source | |
| YALESM-9281 | |||
| 199/14809 | |||
| A5-ETPD |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active rTMS | Experimental | 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 | Placebo Comparator | Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
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PROTOCOL ENTRY CRITERIA:
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Hoffman | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520-8099 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15936729 | Result | 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. |
| Label | URL |
|---|---|
| Click here for the Yale School of Medicine Web site describing current, on-going rTMS trial for auditory hallucinations | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Repetitive Transcanial Magnetic Stimulation | Participants received active repetitive transcranial magnetic stimulation (rTMS) |
| FG001 | Placebo | Participants received sham stimulation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Repetitive Transcanial Magnetic Stimulation | Participants received active repetitive transcranial magnetic stimulation (rTMS) |
| BG001 | Placebo | Participants received sham stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Last Observation Carried Forward (LOCF) | Posted | Dec 2005 | Mean | Standard Deviation | Units on a scale | After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
|
Adverse event reporting was collected for the duration of the study (41 months)
Adverse events were systematically collected with focused questions each day during the trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Repetitive Transcanial Magnetic Stimulation | Participants received active repetitive transcranial magnetic stimulation (rTMS) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | Transient headache and responsive to acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ralph Hoffman | Yale University School of Medicine | 203-688-9734 | ralph.hoffman@yale.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
| 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 |
|
|
| 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 |
| After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
| 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 | After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
| Physician Decision |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Medication Resistance | Number of participants who were medication resistant | Number | Participants |
|
| Total Auditory Hallucination Rate Scale (AHRS) score | Sum of 7 variables: frequency of hallucinations, reality of hallucinations, loudness of hallucinations, number of acoustically distinct voices, length of hallucinations, attentional salience of hallucinations, level of distress induced by hallucinations; higher score connotes more severe hallucinations; lowest score is 4, highest score is 37 | Mean | Standard Deviation | Scores on a scale |
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| Secondary | 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. | LOCF | Posted | Dec 2005 | Mean | Standard Deviation | Score on a scale | After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
|
|
|
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| Secondary | 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 | Posted | Dec 2005 | Mean | Standard Deviation | Units on a scale | After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
|
|
|
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| Secondary | 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 | LOCF | Posted | Number | Participants | After the 9th active/sham rTMS session (up to 2 weeks or end of intervention) |
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| 0 |
| 27 |
| 16 |
| 27 |
| EG001 | Placebo | Participants received sham stimulation | 0 | 23 | 3 | 23 |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |