Effects of Transcranial Focused Ultrasound on Human Primary Motor Cortex Using 7T fMRI

NCT03634631 | Completed

• 1 other identifier: 1508M77355
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

Transcranial focused ultrasound (tFUS) is a form of neuromodulation that uses a single element transducer to produce highly focused low-intensity acoustic energy that can be used to affect cortical excitability in humans. This technology has an advantage over existing electric and electromagnetic technologies in that it has very high spatial resolution and can be focused deep to the cortical surface to target sub-cortical neural structures and circuits. Previous research has shown that tFUS can affect human tactile detection thresholds (Legon et al. 2014a) as well as functional measures of the electroencephalogram (EEG) (Legon et al. 2014a; Mueller et al. 2014a). However, EEG does not provide for detailed spatial mappings and thus the specific spatial extent of the effect of acoustic energy in the cortex is not yet understood. This is an important consideration for the advancement of tFUS as a non-surgical method of stimulation of discrete cortical circuits and small sub-cortical neural structures. Is the effect of tFUS limited to its beam maxima? Does the effect extend along the beam path? And if so, to what extent? These questions can be answered if tFUS is combined with magnetic resonance imaging (MRI).

Conditions

Ultrasound in MRI

Outcome Measures

Primary Outcomes (1)

• Primary motor cortex BOLD signal

  Primary motor cortex BOLD signal

  30 minutes

Interventions

Focused Ultrasound OTHER

Test ultrasound in 7T MRI scanner

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of age Provide written informed consent

You may not qualify if:

• 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 Pregnancy 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

Sponsors & Collaborators

• University of Minnesota: lead

Related Publications (1)

• Ai L, Bansal P, Mueller JK, Legon W. Effects of transcranial focused ultrasound on human primary motor cortex using 7T fMRI: a pilot study. BMC Neurosci. 2018 Sep 14;19(1):56. doi: 10.1186/s12868-018-0456-6.

  PMID: 30217150 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: January 1, 2017
• Primary Completion: August 11, 2018
• Study Completion: August 11, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share