Trochlear Nerve PalsyNCT03099473
Effects of Ocular Electroacupuncture on Trochlear Nerve Palsy
A study testing ocular electroacupuncture and ocular acupuncture in people with Trochlear Nerve Palsy, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trochlear Nerve Palsy
- What is being tested?
- ocular electroacupuncture and ocular acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with confirmed diagnosis of trochlear nerve palsy made by neurologist or ophthalmologist;
- patient in stable condition after treatment for primary disease;
- age between 18 to 80 years old without gender limitation;
- haven't received acupuncture intervention for TNP before;
- patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.
Who cannot join
- those with other diagnosed medical conditions known to contribute to TNP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
- those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
- those with serious medical conditions that might limit their participation;
- those with eye or other location with serious infections;
- women who had a positive pregnancy test or who were planning to become pregnant during the study period;
- those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
- who had participate in other clinical trials, which may affect the results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Lingyun Zhou, PhD, +86 13351113936, no1zhly@163.com
Tiejuan Liu, PhD, +86 13946062207, ltj850722@126.com
About this study
Official title: A Randomized Trial of Ocular Electroacupuncture for Trochlear Nerve Palsy
The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.
Read the detailed description
The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for trochlear nerve palsy (TNP), through treating TNP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by trochlear nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.
- Conditions
- Trochlear Nerve Palsy
- Being tested
- ocular electroacupuncture, ocular acupuncture, sham acupuncture
- Keywords
- electroacupuncture, trochlear nerve palsy, eyeball movement, diplopia, ocular motility disorder
- Medical subject headings
- Trochlear Nerve Diseases, Diplopia, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocular electroacupunctureOther
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 acupunctureOther
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 acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ocular electroacupuncture | Experimental | Patients will receive electroacupuncture for 40 mins with certain parameter at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve. Receives: Other: ocular electroacupuncture |
| ocular acupuncture | Experimental | Patients will receive acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve. Receives: Other: ocular acupuncture |
| sham acupuncture | Sham comparator | Patients will receive sham acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve. When the care provider performed operating acupuncture, the needles of sham acupuncture set will not be inserted into the skin of patient. Receives: Other: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Angle of diplopia deviation at 6 Weeks
Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically. The changes from baseline will be recorded.
Measured: 6 week
Secondary outcomes (1)
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start6 Apr 2017 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trochlear Nerve PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingyun Zhou, PhD, Study chair, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099473
- Sponsor's protocol ID
- 2017031602
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Ocular Electroacupuncture for Trochlear Nerve Palsy
- ClinicalTrials.gov ID
- NCT03099473
- Acronym / sponsor ID
- 2017031602
- Conditions
- Trochlear Nerve Palsy
- Keywords
- electroacupuncture, trochlear nerve palsy, eyeball movement, diplopia, ocular motility disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 6 Apr 2017 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.
Detailed description
The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for trochlear nerve palsy (TNP), through treating TNP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by trochlear nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ocular electroacupuncture | Experimental | Other: ocular electroacupuncturePatients will receive electroacupuncture for 40 mins with certain parameter at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve. |
| ocular acupuncture | Experimental | Other: ocular acupuncturePatients will receive acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve. |
| sham acupuncture | Sham comparator | Other: sham acupuncturePatients will receive sham acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve. When the care provider performed operating acupuncture, the needles of sham acupuncture set will not be inserted into the skin of patient. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient with confirmed diagnosis of trochlear nerve palsy made by neurologist or ophthalmologist;
- patient in stable condition after treatment for primary disease;
- age between 18 to 80 years old without gender limitation;
- haven't received acupuncture intervention for TNP before;
- patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.
Key exclusion criteria (7 listed)
- those with other diagnosed medical conditions known to contribute to TNP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
- those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
- those with serious medical conditions that might limit their participation;
- those with eye or other location with serious infections;
- women who had a positive pregnancy test or who were planning to become pregnant during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ocular electroacupunctureDuring 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. | Other | ocular electroacupuncture |
| ocular acupunctureDuring 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. | Other | ocular acupuncture |
| sham acupunctureDuring 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. | Other | sham acupuncture |
Primary outcome
Change from Baseline in Angle of diplopia deviation at 6 Weeks
Time frame: 6 week
Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically. The changes from baseline will be recorded.
1 secondary outcome
The quality of life questionnaire for ocular motor nerve palsy
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Trochlear Nerve Palsy
RecruitingObservational study
Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies
Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingyun Zhou, PhD study chair
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ocular electroacupuncture and ocular acupuncture in people with Trochlear Nerve Palsy, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LingYun Zhou, PhD (+86 13351113936, no1zhly@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Angle of diplopia deviation at 6 Weeks (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.