NCT01629901

Brief Summary

This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 21, 2017

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

June 26, 2012

Last Update Submit

March 20, 2017

Conditions

Healthy Volunteer

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Changes in cerebral blood flow

    Changes in cerebral blood flow will be quantified through the use of bilateral transcranial Doppler (TCD). The baseline TCD of three vessels will be compared with measurements taken at 30 second intervals for 5 minutes after caloric stimulation.

    20 minutes

Secondary Outcomes (2)

  • Alterations in EEG readings

    40 minutes

  • Alterations in regional cerebral brain flow (rCBF)

    40 minutes

Interventions

ThermoNeuroModulation (TNM) DeviceDEVICE

Non-invasive neurostimulator used for up to 20 minutes in a session.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no history of neurological disease

You may not qualify if:

  • persons under the age of 18
  • pregnant or nursing women
  • history of neurological disease
  • history of psychiatric disease
  • congenital heart defect, known cardiac shunt
  • inner ear or pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Neoplasm Staging

Intervention Hierarchy (Ancestors)

PrognosisDiagnosis

Study Officials

  • Daniel Laskowitz, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

March 21, 2017

Record last verified: 2015-06

Locations

US(1)