The Effects of Ultrasound on Central Nervous System

University of Virginia

Status: Unknown

Conditions: Focused Ultrasound

Treatments: Other: Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04192149

21331

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 5 patient groups

Patients receiving Craniotomy

Experimental group

Description:

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.

Treatment:

Other: Focused Ultrasound

Epilepsy Patients

Experimental group

Description:

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.

Treatment:

Other: Focused Ultrasound

Tremor Patients receiving FUS

Experimental group

Description:

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.

Treatment:

Other: Focused Ultrasound

Tremor Patients receiving DBS

Experimental group

Description:

Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive Focused Ultrasound stimulation observed through their newly implanted electrode.

Treatment:

Other: Focused Ultrasound

Patients receiving Spinal Surgery

Experimental group

Description:

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.

Treatment:

Other: Focused Ultrasound