NCT03289572

Brief Summary

Neurologic disease with loss of motor function is a major health burden. Brain-computer interfaces (BCI) are systems that use brain signals to power an external device, such as a communication board or a prosthetic device, which may help people with loss of motor function. Electrocorticography (ECoG) has been used to decode hand movements and as a control signal for brain-computer interface (BCI). This study hopes to use a smaller spacing of ECoG to see if a better motor signal can be found and used as a BCI control signal.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

8.1 years

First QC Date

September 15, 2017

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • This is an observational study and the outcome is successful measurement of motor-related corticography signals.

    Successful measurement of motor-related corticography signals

    7-10 days

Eligibility Criteria

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

Patients with intractable epilepsy ages 18 and above scheduled to undergo grid placement for epilepsy treatment.

You may qualify if:

  • Must be able to speak and read English
  • Cognitive ability to follow study directions
  • Patients that are scheduled to undergo grid placement clinically for treatment of
  • intractable epilepsy
  • years of age or older

You may not qualify if:

  • Patients who are not considered candidates for epilepsy surgery
  • Individuals who have a diagnosis that would not allow them to participate in research procedures. For example, a physical disability that would limit hand movements and range of motion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jeffrey G Ojemann, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy m Anderson, BSN

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Neurological Surgery

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 21, 2017

Study Start

November 1, 2015

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations