- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01072617
Cerebellar rTMS for the Treatment of Schizophrenic Patients
Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age between 18-65 years
- Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
Exclusion Criteria:
- Prior neurosurgical procedures
- Any history of seizure
- Previous head injury
Contraindication to TMS:
- Implanted pacemaker
- Medication pump
- Vagal stimulator
- Deep brain stimulator
- Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
- Signs of increased intracranial pressure
- TENS unit and ventriculo-peritoneal shunt
- Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
- Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year
- A history of significant alcohol or drug abuse in the prior six months
- No focal cortical insult can be present, including tumor or vascular malformation
- Patients may not be actively enrolled in a separate intervention study
Patients unable to undergo a brain MR:
a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).
- Change in antipsychotic medication during the last 4 weeks
- Any emergency psychiatry department visit during the last 4 weeks
- Been an inpatient in a psychiatry clinic within the last month
- Any other axis I diagnosis
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Safety of rTMS in schizophrenia patients
Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
|
Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Adverse Events
Lasso di tempo: 3 weeks
|
Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.
|
3 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Lasso di tempo: Baseline, 5 days (post-treatment), 1 week post treatment
|
Potential 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.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment.
The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
|
Baseline, 5 days (post-treatment), 1 week post treatment
|
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale
Lasso di tempo: Baseline, 5 days (post-treatment), 1 week post treatment
|
Potential 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.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment.
The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
|
Baseline, 5 days (post-treatment), 1 week post treatment
|
Positive and Negative Syndrome Scale (PANSS) - General Subscale
Lasso di tempo: Baseline, 5 days (post-treatment), 1 week post treatment
|
Potential 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.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment.
The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
|
Baseline, 5 days (post-treatment), 1 week post treatment
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Alvaro Pascual-Leone, MD, PhD, Beth Israel Deaconess Medical Center
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2007P000395
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 .