The Effects of Ultrasound on Central Nervous System
キーワード
概要
説明
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.
日付
最終確認済み: | 11/30/2019 |
最初に提出された: | 03/18/2019 |
提出された推定登録数: | 12/04/2019 |
最初の投稿: | 12/09/2019 |
最終更新が送信されました: | 12/04/2019 |
最終更新日: | 12/09/2019 |
実際の研究開始日: | 02/18/2019 |
一次完了予定日: | 02/19/2021 |
研究完了予定日: | 02/19/2021 |
状態または病気
介入/治療
Other: Focused Ultrasound
段階
アームグループ
腕 | 介入/治療 |
---|---|
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. |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | 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 |
結果
主な結果の測定
1. Electrophysiological Changes as a result of Ultrasound [baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)]