NCT01377766

Brief Summary

The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine whether psychological factors are the potential risk factors for the occurrence of BP.

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
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

June 20, 2011

Last Update Submit

November 5, 2011

Conditions

Keywords

Bell's palsypsychological stresspersonality factorspsychological factors

Outcome Measures

Primary Outcomes (1)

  • House-Brackmann scale (HBS)

    within 168 hours after onset of symptoms

Eligibility Criteria

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

695 subjects were assigned to Cases Group (n=355) and Control Group (n=340).

You may qualify if:

  • Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
  • aged 18 to 65 years.

You may not qualify if:

  • illiterate;
  • the facial paralysis is caused by herpes zoster;
  • recurrent facial paralysis;
  • noticeable asymmetry of the face before the illness which may affect the evaluation;
  • history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Integrated Traditional Chinese and Western Medicine

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Bell PalsyStress, Psychological

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Wei Wang, doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Wang, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurology and Psychology, Tongji Hospital

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 21, 2011

Study Start

October 1, 2008

Primary Completion

October 1, 2010

Study Completion

November 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations