Effects of Ocular Electroacupuncture on Abducens Nerve Palsy

Abducens Nerve Paralysis Clinical Trial

Official title:

A Randomized Trial of Ocular Electroacupuncture for Abducens Nerve Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03099460
• Other study ID #: 2017031601
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2017
• Last updated: March 28, 2017
• Start date: April 6, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2017
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: LingYun Zhou, PhD
• Phone: +86 13351113936
• Email: no1zhly[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to testify the efficacy of treating abducens nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.

Description:

The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for abducens nerve palsy (ANP), through treating ANP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by abducens nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Criteria: Inclusion criteria;

1. patient with confirmed diagnosis of abducens nerve palsy made by neurologist or ophthalmologist;

2. patient in stable condition after treatment for primary disease;

3. age between 18 to 80 years old without gender limitation;

4. haven't received acupuncture intervention for ANP before;

5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.

Exclusion criteria:

1. those with other diagnosed medical conditions known to contribute to ANP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;

2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;

3. those with serious medical conditions that might limit their participation;

4. those with eye or other location with serious infections;

5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;

6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;

7. who had participate in other clinical trials, which may affect the results.

Related Conditions & MeSH terms

• Abducens Nerve Paralysis
• Paralysis

Intervention

Other:
• ocular electroacupuncture
During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.
• ocular acupuncture
During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm.The duration of intervention is 40 minutes.
• sham acupuncture
During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm sham needle set is stick onto insertion area without piercing into the skin. The duration of intervention is 40 minutes.

Locations

Country	Name	City	State
China	The first affiliated hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Ocular Motility Rating Score at 6 Weeks	The patient will receive grading of eyeball outward moving ability by investigator. The changes of rating score from baseline will be recorded.	6 week
Secondary	Angle of diplopia deviation	Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically.	6 week
Secondary	Eyeball movement distance	The distances of eyeball movement in outward direction will be measured. The differences between affected and healthy eye will be calculated.	6 week
Secondary	The quality of life questionnaire for ocular motor nerve palsy	The patients will finish a questionnaire to evaluate their physical and psychological status during this trial.	6 week