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- Ensayo clínico NCT02446067
Cerebral Hemodynamics With rTMS in Alcohol Dependence
Cerebral Hemodynamics With rTMS in Alcohol Dependence: A Randomized, Sham Controlled Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Alcohol abuse is a worldwide problem causing serious physical, psychological, social and economic consequences. Chronic alcohol intake has been found to increased blood viscosity, erythrocyte deformability or dehydration resulting in alterations of cerebral blood flow measures. Transcranial Doppler (TCD) sonography is a non-invasive radiological tool used for assessing the hemodynamics of the basal cerebral arteries, which can thus indirectly reflect the relative changes in regional cerebral blood flow velocity (CBFV) and vascular wall resistance. It has been used to evaluate the relative cerebral blood flow velocity changes in various psychiatric disorders like depression, schizophrenia, panic disorder, and substance use disorders including alcohol and marijuana. TCD also gives a real time assessment of the abrupt or short and long lasting effects of any external mechanical manipulation or functional stimulation of the intracranial circulation.
The Mean flow velocity (MV) is the average of the edge frequency over a cardiac cycle; the edge frequency being the envelope of instantaneous peak velocities throughout the course of a cardiac cycle. Pulsatility index (PI) represents an estimate of downstream vascular resistance; low resistance vascular beds have higher diastolic flow velocities than high resistance vascular beds, hence they have low PI, and vice versa. Similarly, Resistance index (RI) is another presumptive measure of downstream vascular resistance.
TCD sonography studies in alcoholism have revealed reduced mean blood flow velocities in basal cerebral arteries in chronic alcohol dependence, [1] as well as in acute stage of intoxication, but an increase after resolution of withdrawal state. [12] However, ethanol in low concentration has been found to increase the systolic, diastolic and mean blood flow velocity in middle cerebral arteries (MCA), anterior cerebral arteries (ACA) and decrease the resistance indices by reducing the cerebrovascular resistance in healthy individuals. Studies have reported that alcohol related hepatic dysfunction results in increased blood viscosity and reduced velocity in the cerebral arteries, which can be a risk factor for ischemic brain diseases. So, normalization of hemodynamic parameters is important in the prevention of possible ischemic brain diseases due to alcohol dependence.
Studies evaluating cerebral hemodynamic response to rTMS application have been limited to healthy individuals, with high frequency rTMS application found to increase the cerebral blood flow velocities in both anterior and posterior basal cerebral arteries, and low frequency rTMS to temporarily decrease the blood flow velocity in ipsilateral MCA followed by an increase in the contralateral MCA. With this background, the present study was conducted to measure the cerebral hemodynamic indices of alcohol dependent patients and observe the relative changes in these parameters with rTMS application.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Jharkhand
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Ranchi, Jharkhand, India, 834006
- Central Institute of Psychiatry
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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:
- Right handed, male patients, aged between 18-60 years, with diagnosis of alcohol dependence according to DSM-IV TR, after resolution of withdrawal symptoms i.e. having Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) score of ≤10, were included in the study.
Exclusion Criteria:
- Patients with comorbid psychiatric, major medical or neurological disorders or with a pacemaker or metal in any part of the body were excluded from the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Healthy control
No Repetitive Transcranial Magnetic Stimulation (rTMS)
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Comparador activo: Active rTMS group
Active Repetitive Transcranial Magnetic Stimulation (rTMS)
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The motor threshold for the left abductor pollicis brevis was determined using a figure-of-eight-shaped coil at 1 Hz frequency.
Ten (over 2 weeks) rTMS sessions were administered over the right dorsolateral prefrontal cortex with an air-cooled figure-of-eight coil, angled tangentially to the head.
At right DLPFC, active high-frequency (10 Hz) stimulation was administered for 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session.
Each patient received 1000 pulses per day.
The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
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Comparador falso: Sham rTMS group
Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
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The motor threshold for the left abductor pollicis brevis was determined using a figure-of-eight-shaped coil at 1 Hz frequency.
Ten (over 2 weeks) rTMS sessions were administered over the right dorsolateral prefrontal cortex with an air-cooled figure-of-eight coil, angled tangentially to the head.
At right DLPFC, active high-frequency (10 Hz) stimulation was administered for 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session.
Each patient received 1000 pulses per day.
The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Mean velocity (MV) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
Periodo de tiempo: up to 5 minutes after last (10th) rTMS session
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up to 5 minutes after last (10th) rTMS session
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Pulsatility index (PI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
Periodo de tiempo: up to 5 minutes after last (10th) rTMS session
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up to 5 minutes after last (10th) rTMS session
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Resistance index (RI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
Periodo de tiempo: up to 5 minutes after last (10th) rTMS session
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up to 5 minutes after last (10th) rTMS session
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Gdovinova Z. Blood flow velocity in the middle cerebral artery in heavy alcohol drinkers. Alcohol Alcohol. 2001 Jul-Aug;36(4):346-8. doi: 10.1093/alcalc/36.4.346.
- Pecuch PW, Evers S, Folkerts HW, Michael N, Arolt V. The cerebral hemodynamics of repetitive transcranial magnetic stimulation. Eur Arch Psychiatry Clin Neurosci. 2000;250(6):320-4. doi: 10.1007/s004060070007.
- de Castro AG, Bajbouj M, Schlattmann P, Lemke H, Heuser I, Neu P. Cerebrovascular reactivity in depressed patients without vascular risk factors. J Psychiatr Res. 2008 Jan;42(1):78-82. doi: 10.1016/j.jpsychires.2006.10.001. Epub 2006 Nov 20.
- Mathew RJ, Wilson WH. Substance abuse and cerebral blood flow. Am J Psychiatry. 1991 Mar;148(3):292-305. doi: 10.1176/ajp.148.3.292.
- Gdovinova Z. Cerebral blood flow velocity and erythrocyte deformability in heavy alcohol drinkers at the acute stage and two weeks after withdrawal. Drug Alcohol Depend. 2006 Feb 28;81(3):207-13. doi: 10.1016/j.drugalcdep.2005.07.006. Epub 2005 Aug 29.
- Blaha M, Aaslid R, Douville CM, Correra R, Newell DW. Cerebral blood flow and dynamic cerebral autoregulation during ethanol intoxication and hypercapnia. J Clin Neurosci. 2003 Mar;10(2):195-8. doi: 10.1016/s0967-5868(02)00126-1.
- Stendel R, Irnich B, al Hassan AA, Heidenreich J, Pietilae T. The influence of ethanol on blood flow velocity in major cerebral vessels. A prospective and controlled study. Alcohol. 2006 Apr;38(3):139-46. doi: 10.1016/j.alcohol.2006.06.005. Epub 2006 Jul 28.
- Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
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 (Estimar)
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
- CIPRanchi
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Ensayos clínicos sobre Dependencia al alcohol
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Karolinska InstitutetTerminadoConsumo de alcohol | Dependencia al alcohol | Alcohol; Uso nocivo | Trastorno por consumo de alcohol | Abuso de alcoholSuecia
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Charles Drew University of Medicine and ScienceRetiradoConsumo de alcohol | Trastorno por consumo de alcohol | Abuso de alcohol | Problema de alcohol
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University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyTerminadoBebiendo alcohol | Consumo, AlcoholNueva Zelanda
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HBSAReclutamientoConsumo excesivo de alcohol, consumo de alcohol por menores de edad, beber y conducir, daños relacionados con el alcoholEstados Unidos
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Karolinska InstitutetRegion StockholmTerminadoDependencia al alcohol | Trastorno por consumo de alcohol | Abuso de alcohol | Uso nocivo de alcoholSuecia
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Boston Medical CenterBoston University; National Institute on Alcohol Abuse and Alcoholism (NIAAA)TerminadoDependencia al alcohol | Abuso de alcohol | Uso no saludable de alcohol | Cantidades peligrosas de consumo de alcohol | Uso peligroso de alcoholEstados Unidos
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University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Activo, no reclutandoAlcohol; uso, problemaEstados Unidos
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University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)TerminadoAlcohol; uso, problemaEstados Unidos
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University of Central FloridaInscripción por invitación
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University of ThessalyEuropean Social FundTerminadoDependencia al alcohol | Trastorno por consumo de alcohol | Consumo excesivo de alcohol | Abuso de alcohol
Ensayos clínicos sobre Repetitive Transcranial Magnetic Stimulation (rTMS)
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University of ArkansasReclutamientoAfasiaEstados Unidos
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Minneapolis Veterans Affairs Medical CenterCenter for Veterans Research and EducationTerminadoObesidad | Impulsividad | Comer en exceso compulsivamenteEstados Unidos
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VA Office of Research and DevelopmentTerminadoCarrera | Lesión cerebral traumática | Deterioro cognitivo moderadoEstados Unidos