N/A N=22 Randomized Double-blind Treatment

A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00168311 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Scale for the Asessment of Negative Symptoms (SANS) — 38.8; 53.7 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcranial Magnetic Stimulation (Device); sham TMS (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Alfred
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Scale for the Asessment of Negative Symptoms (SANS)	38.8; 53.7	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

DSM-IV diagnosis of schizophrenia or schizoaffective disorder, age over 18
Persistent negative symptoms of moderate to severe intensity
Failure to respond to a minimum of two antipsychotic medications
No increase or initiation of new antipsychotic therapy in the four weeks prior to entering the trial

Exclusion Criteria

Prominent positive symptoms
Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
Subjects at high risk of violence or suicide as determined by the investigator and treating clinicians
Substance dependence

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Data sourced from ClinicalTrials.gov (NCT00168311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.