- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00168311
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia (rTMS)
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magentic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia and Related Disorders
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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:
- Diagnostic and Statistical Manual-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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Victoria
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Melbourne, Victoria, Australia, 3181
- Alfred Psychiatry Research Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Active Treatment
Bilateral high frequency (10 Hertz) rTMS
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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.
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Comparatore fittizio: Sham rTMS
Bilateral Sham rTMS
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Scale for the Asessment of Negative Symptoms (SANS)
Lasso di tempo: 3 weeks
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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.
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3 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Paul B Fitzgerald, MBBS, PhD, Alfred Psychiatry Research Centre
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 81/02
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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