Clinical trial NCT02382965: Ultrasound in Deep Brain Stimulation
Official title: Transcranial Focused Ultrasound for Deep Brain Stimulation in Humans
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sub-cortical Stimulation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults will be enrolled for Transcranial Focused Ultrasound for Deep Brain Stimulation

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Somatosensory evoked potential amplitude
timeFrame: one year
Secondary outcomes:
Other outcomes:
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