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There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal cortex in the treatment of negative symptoms. Neuroimaging studies demonstrate abnormal activity in this region in patients experiencing negative symptoms. Finally rTMS applied at high frequency shows the capacity to up-regulate cortical activity in a way that would provide an explanation for a therapeutic response.
The study involves participants receiving 15 sessions of high frequency rTMS treatment applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS. Following this double blind phase, participants randomised to placebo treatment will be offered 15 sessions of active treatment.
In addition, ppTMS (paired pulse TMS) will be conducted prior to the onset of treatment and after completion of the course, as a means of measuring cortical inhibition and facilitation. NIRS (Near Infra red spectroscopy) will also be conducted prior to, during and after the first and last treatment sessions to allow monitoring of oxygenated and deoxygenated haemoglobin.
The main outcome measure used is the SANS (Scale for the Assessment of Negative Symptoms. This is a semi strucutured interview which provides scores from 0-70. This is administered at baseline, week 2, 3, 5 and 6.
Other outcome measures administered are (frequency mentioned above): PANSS (Positive and Negative Syndrome Scale) and the Calgery Depression Scale for Schizophrenia, A cognitive battery is also administered.
Inclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Bilateral high frequency (10 Hertz) rTMS |
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| Sham rTMS | Sham Comparator | Bilateral Sham rTMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Scale for the Asessment of Negative Symptoms (SANS) | Scale for Assessment of Negative Symptoms [SANS]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of >50 is considered to be a moderate-severe intensity. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul B Fitzgerald, MBBS, PhD | Alfred Psychiatry Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Psychiatry Research Centre | Melbourne | Victoria | 3181 | Australia |
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A total of 20 patients were randomly assigned. Patients were recruited from the outpatient department of two public area mental health services and by referral from a number of private psychiatrists between January 2003 and July 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Bilateral high frequency (10Hz) rTMS |
| FG001 | Sham Treatment | Sham bilateral rTMS treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| sham TMS | Device |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Bilateral high frequency (10Hz) rTMS |
| BG001 | Sham Treatment | Sham bilateral rTMS treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | 16 men and 4 women | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Scale for the Asessment of Negative Symptoms (SANS) | Scale for Assessment of Negative Symptoms [SANS]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of >50 is considered to be a moderate-severe intensity. | Posted | Mean | Standard Deviation | Scores on a scale | 3 weeks |
|
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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 Treatment | Bilateral high frequency (10Hz) rTMS | 0 | 12 | 0 | 12 | ||
| EG001 | Sham Treatment | Sham bilateral rTMS treatment | 0 | 10 | 0 | 10 |
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Insufficient time period used to be able to establish a substantive therapeutic effect of rTMS; standard dosing method may be inadequate due to volumetric changes in brain regions in schizophrenia; concurrent antipsychotic medication.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Paul Fitzgerald | Monash Alfred Psychiatry Research Centre | +61 3 9076 6564 | p.fitzgerald@alfred.org.au |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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