Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy
Effect of Transcranial Direct Current Stimulation on Proprioceptive and Vibratory Sensation: Potential Benefit for Patients With Peripheral Neuropathy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will be performed in patients with peripheral neuropathy who are walking independently, but have complains of balance problems such as recent falls or difficulty walking and show reduced vibratory and proprioceptive sensation during routine neurologic examination. These patients will be tested for proprioceptive and vibratory threshold at the toes and ankles before, during and after receiving anodal transcranial direct current stimulation (tDCS) over sensory and motor cortices. Subjects will be asked to participate in 2 sessions. In one of the sessions, decided randomly, the stimulation will be applied on the right side and in the second session it will be on the left.
The tDCS portion of the experiment will begins with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA). One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital
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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:
- Peripheral Neuropathy
- Walking independently but with problems with balance
Exclusion Criteria:
- Prominent weakness at the ankle
- Not able to walk independently
- History of Seizure
- Cardiac Pacemaker
- Metal implants in the head
- Increased intracranial pressure
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: dTCS
Patient will receive dTCS with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA) or Sham stimulation.
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Direct current (DC) (maximum of 2 mA) stimulation delivered through surface electrodes.
One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead.
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Comparador falso: Sham
Patients will receive a sham.
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The device will administer a sham.
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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 in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes
Periodo de tiempo: At 10 and 20 minutes
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Vibration is measured by reading in Rydel Seiffer tuning fork that ranges between 0-8 and is a standard tool fro measuring vibration sensation at the toes.
A reading of 0 means absent vibration.
A reading of more than 4 at the toes are considered normal.
Change between assessment at 20 minutes and 10 minutes at the toes will be assessed.
A recording of less than 4 indicates an abnormal results and a lower number means worse neuropathy.
For example, reading of 0 means absent vibration feeling which indicates worse neuropathy than a reading of 2.
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At 10 and 20 minutes
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Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe
Periodo de tiempo: At 10 and 20 minutes
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At 10 and 20 minutes
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohammad Khoshnoodi, MD, Johns Hopkins University
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 (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00066426
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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