Ultrasound in Deep Brain Stimulation | NCT02382965

Studies
Ultrasound in Deep Brain Stimulation

NCT02382965

Sponsor

University of Minnesota

Status

Terminated

Last Update Posted

Aug 11, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Sub-cortical Stimulation

Interventions

transcranial focused ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left University no data available

Expanded Access Info

Start Date

May 1, 2015Actual

Primary Completion Date

Apr 1, 2017Actual

Completion Date

Apr 1, 2017Actual

First Submitted Date

Mar 3, 2015

First Submission Date that Met QC Criteria

Mar 6, 2015

First Posted Date

Mar 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2022

Last Update Posted Date

Aug 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
ultrasound			Device: transcranial focused ultrasound

Name	Type	Description	Arm Group Labels	Other Names
transcranial focused ultrasound	Device		ultrasound

Measure	Description	Time Frame
Somatosensory evoked potential amplitude		one year

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy adults will be enrolled for Transcranial Focused Ultrasound for Deep Brain Stimulation

Sampling Method

Probability Sample