An interventional study of Transcranial Magnetic Stimulation and sham TMS in Schizophrenia, sponsored by The Alfred. Completed at 1 site in Australia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-05-14.
Sponsored by The Alfred · Not applicable, Interventional, and Treatment
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:
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 22 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →The Alfred is the lead sponsor of 45 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bilateral high frequency (10 Hertz) rTMS
Device: Transcranial Magnetic Stimulation
Bilateral Sham rTMS
Device: sham TMS
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.
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.
Time frame: 3 weeks
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.
| Milestone | Active Treatment | Sham Treatment |
|---|---|---|
| Started | 12 | 10 |
| Completed | 12 | 8 |
| Not completed | 0 | 2 |
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.
| Scores on a scale | Active Treatment | Sham Treatment |
|---|---|---|
| Scale for the Asessment of Negative Symptoms (SANS) | 38.8 ± 11.0 | 53.7 ± 8.3 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Treatment | — | 0/12 (0%) | 0/12 (0%) |
| Sham Treatment | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 10 | 22 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 10 | 8 | 18 |
| Region of Enrollment(participants) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| Australia | 12 | 10 | 22 |
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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