NCT02382965

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

March 3, 2015

Last Update Submit

August 9, 2022

Conditions

Sub-cortical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Somatosensory evoked potential amplitude

    one year

Study Arms (1)

ultrasound

Device: transcranial focused ultrasound

Interventions

transcranial focused ultrasoundDEVICE
ultrasound

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 11, 2022

Record last verified: 2022-08