Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study
8 de febrero de 2019 actualizado por: Washington University School of Medicine
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder: A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study
This protocol, "Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study," is an open-label pilot treatment study.
The purpose of the present protocol is to treat participants with a diagnosis of Major Depressive Disorder with 4 weeks of rTMS, performing fcMRI and EEG studies prior to and following treatment to determine if treatment response is related to changes in fcMRI and/or EEG results.
The investigators hypothesize that patients who respond to treatment will display changes in functional connectivity patterns thought to be related to the occurrence of depressive symptoms.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Depression is accompanied by rumination that supports inwardly focused cognitive attention on negative events and emotions.
There is evidence to indicate that one aspect of this ruminative behavior lies in an abnormal increase in intra-regional connectivity among elements of the default mode network (DMN).
It is also widely recognized that depression is associated with disturbances of cognition that include deficits in attentional processing, including both reductions in processing speed and deficits in selective attentional processing that are considered a part of executive function.
Thus, there is at least equal reason to believe that attention and executive control networks might show changes in intra-regional functional connectivity.
Given the attentional deficits associated with MDD, we hypothesize that there will be a weakening of intra-network resting state BOLD functional connectivity (rs-fcMRI) in addition to the strengthened connectivity reported by others.Further, we suggest that these shifts in intra-regional connectivity extend to the well-recognized anti-correlated activity between these two networks and support the intrusion of introspective, ruminative thought on cognitive activities that require externally directed attention.
To test this hypothesis, we will use fMRI resting state functional connectivity to examine shifts in network connectivity prior to and following rTMS treatment for depression.
Tipo de estudio
Intervencionista
Inscripción (Actual)
4
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
SCREENING/DIAGNOSTIC REQUIREMENTS:
- Male or female outpatients, ages 18-50 (some literature has shown increasing cortical distance with age that may affect treatment outcome
- Hamilton Rating Scale of Depression (HRSD-24) > 18
- New onset major depression or untreated recurrent major depression per DSM-IV-TR38 criteria.
- Not taking antidepressant medication or any other psychotropic medication
- Using an adequate contraceptive method
- Able to give informed consent
- Available for 4 weeks of daily therapy, working hours, Mon.-Fri.
- English-speaking
Exclusion Criteria:
DIAGNOSTIC EXCLUSIONS:
- Co-morbid psychiatric diagnosis of bipolar disorder, acute OCD, schizophrenia or schizoaffective or concurrent treatment with outpatient ECT, or personality disorder or MDD with suicidal ideation as determined by history and/or by P.I. examination requiring hospital admission or referral for acute care.
- Previous failure to respond to treatment with rTMS
- Failure to achieve satisfactory improvement in depression after two or more adequate trials of antidepressant medications.
MEDICAL EXCLUSIONS:
- Patients newly diagnosed with thyroid dysfunction
- History of drug and/or ETOH dependence
- History of seizures
- History of head injury with loss of consciousness > 5 minutes
- Any implantable metal object in the skull or near their head
- Any implantable devices such as a cardiac pacemaker, vagal nerve stimulator, etc.
- Positive urine pregnancy test
- Severe migraine headaches uncontrolled with routine non-narcotic medication
- Any medical condition in the opinion of the Investigator that might confound the results of the study Contraindications to fcMRI procedure
- Intake of NSAIDS, narcotic or muscle relaxants within 72 hours of the fMRI protocol.
- Claustrophobia.
- Left-handedness (may influence cerebral cortical hemispheric dominance).
- Inability to tolerate, or medical contraindication to MRI testing (e.g. metal prostheses or implants, history of claustrophobia)
PROTOCOL SPECIFIC EXCLUSIONS:
- Unable to determine motor threshold for determining treatment dose with rTMS device
- Mini Mental Status Exam (MMSE)70 score < 24.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Transcranial Magnetic Stimulation
Open-label transcranial magnetic stimulation
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Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex.
Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hamilton Depression Rating Scale-24 Point Version (HDRS-24)
Periodo de tiempo: At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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HDRS-24 will be used to measure response to rTMS treatment.
A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 < 10 will indicate remission.
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At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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fCMRI Results
Periodo de tiempo: At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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Imaging studies will be compared to determine if any changes in functional connectivity can be correlated with treatment response.
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At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jose Garcia, MD, Washington University School of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
- Demitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharmacol Bull. 2009;42(2):5-38.
- Broyd SJ, Demanuele C, Debener S, Helps SK, James CJ, Sonuga-Barke EJ. Default-mode brain dysfunction in mental disorders: a systematic review. Neurosci Biobehav Rev. 2009 Mar;33(3):279-96. doi: 10.1016/j.neubiorev.2008.09.002. Epub 2008 Sep 9.
- Savitz JB, Drevets WC. Imaging phenotypes of major depressive disorder: genetic correlates. Neuroscience. 2009 Nov 24;164(1):300-30. doi: 10.1016/j.neuroscience.2009.03.082. Epub 2009 Apr 7.
- Zou K, Deng W, Li T, Zhang B, Jiang L, Huang C, Sun X, Sun X. Changes of brain morphometry in first-episode, drug-naive, non-late-life adult patients with major depression: an optimized voxel-based morphometry study. Biol Psychiatry. 2010 Jan 15;67(2):186-8. doi: 10.1016/j.biopsych.2009.09.014.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2010
Finalización primaria (Actual)
1 de septiembre de 2013
Finalización del estudio (Actual)
1 de septiembre de 2013
Fechas de registro del estudio
Enviado por primera vez
30 de noviembre de 2009
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2010
Publicado por primera vez (Estimar)
14 de julio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
8 de febrero de 2019
Última verificación
1 de febrero de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WUSM3621222-201110079
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .