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The Effects of Ultrasound on Central Nervous System

Només els usuaris registrats poden traduir articles
Inicieu sessió / registreu-vos
L'enllaç es desa al porta-retalls
EstatReclutament
Patrocinadors
University of Virginia

Paraules clau

Resum

Focused ultrasound at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. The purpose of this study is to better understand the effects of low intensity focused ultrasound (FUS) on the central nervous system. Specific patient populations within UVA health system are undergoing treatment that provide unique opportunities to study these effects.

Descripció

Focused ultrasound (FUS) at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. In this study the investigators intended to use specific patient populations to investigate the effects of FUS on different areas of the central nervous system (CNS). Each of our patients groups is undergoing a unique procedure at University of Virginia that will provide us different insights into the CNS. (1) Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive FUS mapping. (2) Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of FUS stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care. (3) Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity FUS research procedure and changes in their tremor will be monitored. (4) Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive FUS stimulation observed through their newly implanted electrode. (5) Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive FUS stimulation.

Dates

Darrera verificació: 11/30/2019
Primer enviat: 03/18/2019
Inscripció estimada enviada: 12/04/2019
Publicat per primera vegada: 12/09/2019
Última actualització enviada: 12/04/2019
Publicació de l'última actualització: 12/09/2019
Data d'inici de l'estudi real: 02/18/2019
Data estimada de finalització primària: 02/19/2021
Data estimada de finalització de l’estudi: 02/19/2021

Condició o malaltia

Focused Ultrasound

Intervenció / tractament

Other: Focused Ultrasound

Fase

-

Grups de braços

BraçIntervenció / tractament
Experimental: Patients receiving Craniotomy
Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive Focused Ultrasound mapping.
Experimental: Epilepsy Patients
Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of Focused Ultrasound stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care.
Experimental: Tremor Patients receiving FUS
Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity Focused Ultrasound research procedure and changes in their tremor will be monitored.
Experimental: Tremor Patients receiving DBS
Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive Focused Ultrasound stimulation observed through their newly implanted electrode.
Experimental: Patients receiving Spinal Surgery
Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive Focused Ultrasound stimulation.

Criteris d'elegibilitat

Edats elegibles per estudiar 18 Years Per a 18 Years
Sexes elegibles per estudiarAll
Accepta voluntaris saludables
Criteris

Inclusion Criteria:

- Be a patient receiving a treatment or surgical procedure specified below:

- Receiving a Craniotomy with brain mapping

- Receiving treatment or monitoring for Epilepsy

- Receiving either FUS or DBS treatment for Tremor

- Receiving a Spinal Surgery for stimulator placement

- Able to provide informed consent

- Must speak English

- Age 18-85

Exclusion Criteria:

- Not receiving one of the specified inclusion procedures

- Unable to provide consent

- Women who self-report pregnancy

- Patients who are currently incarcerated

Resultat

Mesures de resultats primaris

1. Electrophysiological Changes as a result of Ultrasound [baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)]

Each participant group has different type of electrophysiological recording depending on the type of procedure. Recordings will include a baseline, during ultrasound, and/or post-ultrasound electrophysiology.

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