NCT02865317

Brief Summary

Cortical activity during rest and with stimulation by functional magnetic resonance imaging will be investigated in patients with OBPI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 29, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

January 29, 2016

Last Update Submit

August 9, 2016

Conditions

Peripheral Nerve Injury

Outcome Measures

Primary Outcomes (1)

  • voxels

    voxels (n) are the task-activated volume of brain regions

    6 months

Secondary Outcomes (1)

  • Active Movement Scale score

    6 months

Study Arms (1)

Study group

Patients with obstetrical brachial plexus injury involving upper trunk (C5-6)

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with obstetrical brachial plexus palsy

You may qualify if:

  • upper trunk (cervical 5-6) involvement
  • cooperated

You may not qualify if:

  • illiterate
  • surgical history for his arm in the previous 5 years
  • other than only C5-6 involvement
  • any impairment that prevents positioning in MRI machine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2016

First Posted

August 12, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

August 12, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share