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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02128919
Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic (TDCSSCHIZ)
This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine levels, and craving with QSU scale and response to craving slides. Cognition is measured by MCCB, symptoms are measured by PANSS and hallucination scale.
This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days, and sham tDCS for 40 seconds on each sham occasion.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Orangeburg, New York, Estados Unidos, 10962
- Nathan Kline Institute for Psychiatric Research
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of schizophrenia spectrum disorder History of cigarette smoking
Exclusion Criteria:
- Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Active tDCS
tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days
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Transcranial Direct Current Stimulation
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Comparador falso: Sham tDCS
tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
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Transcranial Direct Current Stimulation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Cigarette Craving
Periodo de tiempo: Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
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The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings.
Scores ranged from a minimum of 1 ("Strongly Disagree") to a maximum of 7 ("Strongly Agree") and were determined by self-reported responses to 10 statements about having cravings for smoking.
Scores closer to 1 after treatment would indicate a better outcome.
Responses to each of the 10 items in the scale were summed for one total score.
With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70.
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Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Cognitive Performance
Periodo de tiempo: Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
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The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance.
Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests.
We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data.
The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile).
The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile).
Higher scores after baseline represent better outcomes.
Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.
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Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Psychiatric Symptoms
Periodo de tiempo: Baseline and after 5 tDCS sessions
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The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms.
Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96).
All three subscales were summed for the PANSS total score (total scale range: 30-180).
Scores closer to 30 after baseline represented better outcomes.
Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.
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Baseline and after 5 tDCS sessions
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert C Smith, MD, Nathsan Kline Institute for Psychiatric Research
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 309320
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