The Effects of Ultrasound on Central Nervous System
Paraules clau
Resum
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
Intervenció / tractament
Other: Focused Ultrasound
Fase
Grups de braços
Braç | Intervenció / 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 estudiar | All |
Accepta voluntaris saludables | Sí |
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)]