NCT03149224

Brief Summary

The purpose of this study is to characterize specific brain signals elicited by motor disturbances and errors in stroke patients. The patients will perform a motor task using both their affected and unaffected hands. There are two types of errors: low level errors and high level errors. While disturbances (low level errors) have been shown to elicit P300, uncorrectable actions (high level errors) have been shown to elicit ERN. These event related potentials (ERP) have been extensively studied in healthy subjects including a recent paper from our Lab.

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 Oct 2017

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

January 20, 2017

Last Update Submit

May 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Voltage fluctuations resulting from brain activity after patients fail to reach the target

    Change in brain wave activity after patients fail to reach the target as compared with baseline measured in tens of micro-volts

    one year after the first stroke

Eligibility Criteria

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

Stroke patients from Loewenstein Hospital or Bnai Zion medical center who are going through a similar rehabilitation process

You may qualify if:

  • First stroke
  • Rehabilitation time don't exceed one year

You may not qualify if:

  • Mental disorders
  • Additional neuromuscular disease
  • Significant cognitive dysfunction (as defined by a score \<20 on Mini Mental Status Examination).
  • Visual impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bnai Zion

Haifa, Please Select, 34816, Israel

RECRUITING

Loewenstein Hospital

Haifa, Please Select, 34816, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2017

First Posted

May 11, 2017

Study Start

October 1, 2017

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations