Ultrasound in Deep Brain Stimulation

Terminated

• Conditions: Sub-cortical Stimulation
• Interventions: Device: transcranial focused ultrasound

• Registration Number: NCT02382965
• Lead Sponsor: University of Minnesota

Brief Summary

It is the purpose of this proposal to apply tFUS to the ventral posterior lateral (VPL) nucleus of the thalamus in humans.

Detailed Description

Current non-invasive neuromodulatory approaches like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have proven efficacious for inducing transient plastic changes in the human cortex. However, these technologies have poor spatial resolution, suffer from a depth focality tradeoff and experience significant attenuation at depth. Thus, they cannot effectively target neural tissue below the surface of the cortex. Transcranial focused ultrasound (tFUS) is a new and very promising non-surgical low-energy technique for inducing transient plasticity with high spatial resolution, adjustable focus and low tissue attenuation. tFUS has been used safely and effectively for neural stimulation in mouse, rabbit and monkey and my research has shown tFUS to also be a safe and effective method of transient cortical stimulation in humans. Having demonstrated its efficacy in humans for cortical stimulation, the next step is to take advantage of tFUS' high spatial resolution and deep focal lengths to stimulate sub-cortical neural structures. Currently, the only way to stimulate sub-cortical structures involves expensive and risky surgery. It is the purpose of this proposal to test tFUS for sub-cortical stimulation. The ability to individually stimulate small neural structures deep to the cortex without invasive surgery would have broad application in basic neuroscience for the investigation of brain structure and function as well as for the potential diagnosis and therapy of many neurological and psychiatric diseases.

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-09
• Study Start: 2015-05-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 to 65 years of age
• Provide written informed consent

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Exclusion Criteria

• Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder
• History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
• Personal or family history of seizure
• Any history of stroke/transient ischemic attack (TIA)
• Taking any medications that may decrease the threshold for seizure
• Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI
• Failure to follow laboratory or study procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ultrasound	transcranial focused ultrasound	-

Primary Outcome Measures

Name	Time	Method
Somatosensory evoked potential amplitude	one year