NCT01686464

Brief Summary

The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy, called simultaneous "Magnetic and Oxygen Treatment along Meridians and Collaterals" (MOMC), to treat Bell's Palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
882

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 1998

Longer than P75 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, 1998

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

6.6 years

First QC Date

August 28, 2012

Last Update Submit

September 12, 2012

Conditions

Bell's Palsy

Keywords

magneticoxygenBell's Palsyacupuncture

Outcome Measures

Primary Outcomes (1)

  • House-Brackmann scale

    the 20th day of completion of the treatment

Study Arms (2)

Magnetic - Oxygen

EXPERIMENTAL

Magnetic and Oxygen Treatment for Bell's Palsy

Device: Magnetic and Oxygen Treatment

prednisone - valacyclovir

ACTIVE COMPARATOR

prednisone and valacyclovir treatments for bell palsy

Drug: prednisone and valacyclovir treatments

Interventions

prednisone and valacyclovir treatmentsDRUG

patients were administered prednisone as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days.

Also known as: prednisone and valacyclovir
prednisone - valacyclovir
Magnetic and Oxygen TreatmentDEVICE

MOMC treatment was given as daily 20 min section for 10 days with 2\~3 days of intermission between. Oxygen therapy was given simultaneously at a flow rate of 2\~3.0 L / min for the same duration during all acupuncture sections.

Magnetic - Oxygen

Eligibility Criteria

Age10 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Only patients with complete (or nearly complete) non-recurrent facial paralysis (grade 5-6/6) for more than 1 months
  • the first time to onset the disease
  • on one side of the face paralysis
  • willing to finish the whole observation period
  • with written consent form signed by themselves.

You may not qualify if:

  • facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
  • facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
  • patient with Hunt's syndrome
  • pregnant women or women in lactation
  • patients are participating other clinical research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 4th Military Medical University

Xi’an, Shanxi, 710000, China

Location

Related Publications (2)

  • Shafshak TS, Essa AY, Bakey FA. The possible contributing factors for the success of steroid therapy in Bell's palsy: a clinical and electrophysiological study. J Laryngol Otol. 1994 Nov;108(11):940-3. doi: 10.1017/s0022215100128580.

    PMID: 7829945RESULT

  • Finsterer J. Management of peripheral facial nerve palsy. Eur Arch Otorhinolaryngol. 2008 Jul;265(7):743-52. doi: 10.1007/s00405-008-0646-4. Epub 2008 Mar 27.

    PMID: 18368417RESULT

Related Links

MeSH Terms

Conditions

Bell Palsy

Interventions

PrednisoneValacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • yan L wang, Ph .D

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

  • Ping Li, M.D.

    The 4th military medical university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 18, 2012

Study Start

June 1, 1998

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

CN(1)