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Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

14 marzo 2018 aggiornato da: Mark Halko, Beth Israel Deaconess Medical Center

Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia

The aim of this study is to look at the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary outcome is improvement in negative symptoms related to schizophrenia. The investigators are focusing on negative symptoms given their greater resistance to pharmacological and other established therapies. If the investigators trial were to show beneficial effects, its clinical significance would be great.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study builds on the results of a previous phase 1, single-site study in which we demonstrated the safety of image-guided theta burst stimulation (TBS) form of rTMS over the cerebellar vermis (Demirtas-Tatlidede et al., 2010) in eigh patients with schizophrenia.

The primary goal of the present study is to assess efficacy of iTBS to the cerebellar vermis on positive and negative symptoms of schizophrenia. A second, added goal is to investigate the mechanisms of the expected clinical improvement.

Schizophrenia is a leading cause of mental disability and current treatments still remain only partially successful for many patients. Our underlying hypothesis is that modulation of the cerebellar vermis may enhance activity of the neural systems that sub-serve cognition and emotion, reestablish the disturbed cerebellar regulation in schizophrenic patients, and produce clinical improvement.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

22

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02134
        • Beth Israel Deaconess Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age between 18-65 years
  • Diagnosis of schizophrenia according to DSM-IV criteria (Diagnostic and Statistical Manual) by a board-certified psychiatrist

Exclusion Criteria:

  • Preexisting or progressive neurological disorders
  • Prior neurological procedures
  • Previous head injury
  • Change in antipsychotic medication during the last 4 weeks
  • Been an inpatient in a psychiatry clinic within the last month
  • Any other axis 1 diagnosis
  • Patients may not be actively enrolled in a separate intervention study
  • Patients unable to undergo a brain MRI
  • Any unstable medical condition
  • History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform_ EEG, or family history of treatment resistant epilepsy
  • Possible pregnancy. All female participants of child bearing age are required to have a pregnancy test.
  • Any metal in the brain, skull, or elsewhere unless approved by the responsible MD
  • Any medical devices (ie. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
  • Substance abuse (alcohol, amphetamines, cocaine, MDMA [methylenedioxymethamphetamine], ecstasy, PCP [phencyclidine], Angle dust) or dependence within the past six months
  • No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: the patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS (central nervous system) active drugs (the published TMS guidelines review of medications to be considered with TMS)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Active rTMS
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Dispositivo: Repetitive Transcranial Magnetic Stimulation

intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.

Sham participants will undergo the same procedures as those in the active rTMS group.

Altri nomi:
  • Stimolazione magnetica transcranica
  • Stimolazione cerebrale non invasiva
Comparatore fittizio: Sham rTMS
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Dispositivo: Repetitive Transcranial Magnetic Stimulation

intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.

Sham participants will undergo the same procedures as those in the active rTMS group.

Altri nomi:
  • Stimolazione magnetica transcranica
  • Stimolazione cerebrale non invasiva

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale
Lasso di tempo: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale
Lasso di tempo: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale
Lasso di tempo: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness
Lasso di tempo: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient's illness at the time of assessment. Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients. Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Clinical Global Impression (CGI) Global Improvement
Lasso di tempo: Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient's illness has changed compared to baseline. Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline on the Calgary Depression Scale for Schizophrenia
Lasso di tempo: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
The Calgary Depression Scale for Schizophrenia is a 9-item scale that assesses depressive symptoms in patients with schizophrenia. Each item is rated separately and ratings range from 0 to 3. Higher values represent more severe depressive symptoms: 0 indicates an absent symptom and 3 indicates a severe symptom. The overall Calgary Depression Scale score is computed by summing each item. The total Calgary Depression Scale score ranges from 0 to 27, with higher values representing more severe depression in patients with schizophrenia. Change from baseline on the Calgary Depression Scale can range from -27 to +27, with negative values representing an improvement in depressive symptoms and positive values representing worsening depressive symptom severity. Depression was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beth Israel Deaconess Medical Center

Collaboratori

Sidney R. Baer, Jr. Foundation

Investigatori

  • Investigatore principale: Mark Halko, Ph.D., Beth Israel Deaconess Medical Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2012

Completamento primario (Effettivo)

1 novembre 2015

Completamento dello studio (Effettivo)

1 novembre 2015

Date di iscrizione allo studio

Primo inviato

1 marzo 2012

Primo inviato che soddisfa i criteri di controllo qualità

9 marzo 2012

Primo Inserito (Stima)

13 marzo 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 aprile 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 marzo 2018

Ultimo verificato

1 marzo 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2011P000373

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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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