Nerve InjuryEarly Phase 1facial nerveNCT06185426
Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury
A Early Phase 1 study testing Methyprednisolon and low level laser theraphy in people with Nerve Injury and Laser Therapy, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
The objective of the study will be to investigate the effect of low-level diode laser therapy (LLLT) and steroid on facial nerve injury. Thirty five male Wistar rat will randomly be divided into five groups: healthy control (HCG); damage control (DC); laser (LG); steroid (SG); and combined laser and steroid group… Read more about this study
- Who is it for?
- Ages 4 to 6 months, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nerve Injury, Laser Therapy, Methylprednisolone
- What is being tested?
- Methyprednisolon and low level laser theraphy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Feb 2024
- Phase
- Early Phase 1
- 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 4 to 6 months
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- -Thirty-five male Sprague-Dawley rats weighing 200-300 g will be included the study
Who cannot join
- -Rats that are older than 6 months and are not healthy and have impaired facial motor functions will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study will be to investigate the effect of low-level diode laser therapy (LLLT) and steroid on facial nerve injury. Thirty five male Wistar rat will randomly be divided into five groups: healthy control (HCG); damage control (DC); laser (LG); steroid (SG); and combined laser and steroid group (LSG). Right facial nerve electromyography (EMG) data will record after facial nerve damage done and before sacrification at 4th week.The results will be evaluated histopathologically, electrophysiologically and biochemically.
Read the detailed description
The animals will be randomly divided into two control groups, a healthy control group and a damaged control group, and three experimental groups; 7 rats were assigned to each group as follows;
- Healthy Control Group (HCG): Seven rats will be included randomly in this group. No surgical/medical approach will be applied. EMG measurements will betaken over the right facial nerve.
- Damaged Control Group (DCG): Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Laser Group (LG): Facial nerve injury will be created on the right facial nerve. LLLT (Low-Intensity et al.) will be applied 3 times a week for 4 weeks postoperatively, at 830 nm with an optical power output of 30 mW, an energy density of 4 J/cm2, an irradiation area of 0.116 cm2 and an exposure time of 16 s per spot. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Steroid group (SG): Facial nerve injury will be created on the right facial nerve. Intraperitoneal methylprednisolone (1mg/kg/day) will be administered every day for 1 week postoperatively. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Laser+Steroid Group (LSG): Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Conditions
- Nerve Injury, Laser Therapy, Methylprednisolone, Facial Nerve Injuries
- Being tested
- Methyprednisolon and low level laser theraphy
- Keywords
- Facial Nerve Injury, Steroid, Low Level Laser Therapy, Nerve Recovery
- Medical subject headings
- Facial Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyprednisolon and low level laser theraphyDrug
All rats will be anesthetized with ketamine hydrochloride at a dose of 50 mg/kg (i.p) (Ketalar ®, Eczacıbaşı Parke-Davis, İstanbul, Türkiye) and Xylazine HCl (Alfazyne ®, Alfasan International B.V. Woerden, Hollanda) at a dose of 10 mg/kg (intraperitoneal). A right postauricular incision will made under general anesthesia, and an external trunk of the facial nerve will be found. In the DCG and other experimental groups, the facial nerve was dissected, and it will be clamped with an average force of 150 g for about 1 minute. Afterward, the surgical area will be sutured in all rats in the DCG, L, S, and LSG groups. At the end of the 4 weeks of study, tissue samples will be taken from the facial nerve trunk in the control and experimental groups with a second surgical procedure preserved in formalin solution and sent for histopathological and biochemical examination.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group (HCG) | Placebo comparator | Seven rats will be included randomly in this group. No surgical/medical approach will be applied. Receives: Drug: Methyprednisolon and low level laser theraphy |
| Damaged Control Group (DCG): | Active comparator | Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied. Receives: Drug: Methyprednisolon and low level laser theraphy |
| Laser Group (LG) | Experimental | Facial nerve injury will be created on the right facial nerve. LLLT (Low-Intensity et al.) willl be applied 3 times a week for 4 weeks postoperatively, at 830 nm with an optical power output of 30 mW, an energy density of 4 J/cm2, an irradiation area of 0.116 cm2 and an exposure time of 16 s per spot. Receives: Drug: Methyprednisolon and low level laser theraphy |
| Steroid group (SG) | Experimental | Facial nerve injury will be created on the right facial nerve. Intraperitoneal methylprednisolone (1mg/kg/day) will be administered every day for 1 week postoperatively. Receives: Drug: Methyprednisolon and low level laser theraphy |
| Laser+Steroid Group (LSG): | Experimental | Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination. Receives: Drug: Methyprednisolon and low level laser theraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic Analysis
Measuring the amplitude and latency of the action potential occurring in the nerve with electromyography(On facial nerve)
Measured: 1 month
Secondary outcomes (1)
Biochemical Analysis
Determination of MDA and GSH levels in blood samples taken
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Jan 2021
- Primary completion1 Jun 2023
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve InjuryStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Not required.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Gumrukcu, Recep Tayyip Erdogan University
- Investigators
- zeynep gümrükçü, Associate Professor, Study director, RTEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185426
- Sponsor's protocol ID
- RecepTayyipErdoganUni
- Other IDs
- TSA-2020-1045
- Acronym
- facial nerve
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury
- ClinicalTrials.gov ID
- NCT06185426
- Acronym / sponsor ID
- facial nerve / RecepTayyipErdoganUni
- Conditions
- Nerve Injury, Laser Therapy, Methylprednisolone, Facial Nerve Injuries
- Keywords
- Facial Nerve Injury, Steroid, Low Level Laser Therapy, Nerve Recovery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 29 Dec 2023 (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 objective of the study will be to investigate the effect of low-level diode laser therapy (LLLT) and steroid on facial nerve injury. Thirty five male Wistar rat will randomly be divided into five groups: healthy control (HCG); damage control (DC); laser (LG); steroid (SG); and combined laser and steroid group (LSG). Right facial nerve electromyography (EMG) data will record after facial nerve damage done and before sacrification at 4th week.The results will be evaluated histopathologically, electrophysiologically and biochemically.
Detailed description
The animals will be randomly divided into two control groups, a healthy control group and a damaged control group, and three experimental groups; 7 rats were assigned to each group as follows;
- Healthy Control Group (HCG): Seven rats will be included randomly in this group. No surgical/medical approach will be applied. EMG measurements will betaken over the right facial nerve.
- Damaged Control Group (DCG): Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Laser Group (LG): Facial nerve injury will be created on the right facial nerve. LLLT (Low-Intensity et al.) will be applied 3 times a week for 4 weeks postoperatively, at 830 nm with an optical power output of 30 mW, an energy density of 4 J/cm2, an irradiation area of 0.116 cm2 and an exposure time of 16 s per spot. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Steroid group (SG): Facial nerve injury will be created on the right facial nerve. Intraperitoneal methylprednisolone (1mg/kg/day) will be administered every day for 1 week postoperatively. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Laser+Steroid Group (LSG): Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Not required.
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group (HCG) | Placebo comparator | Drug: Methyprednisolon and low level laser theraphySeven rats will be included randomly in this group. No surgical/medical approach will be applied. |
| Damaged Control Group (DCG): | Active comparator | Drug: Methyprednisolon and low level laser theraphyFacial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied. |
| Laser Group (LG) | Experimental | Drug: Methyprednisolon and low level laser theraphyFacial nerve injury will be created on the right facial nerve. LLLT (Low-Intensity et al.) willl be applied 3 times a week for 4 weeks postoperatively, at 830 nm with an optical power output of 30 mW, an energy density of 4 J/cm2, an irradiation area of 0.116 cm2 and an exposure time of 16 s per spot. |
| Steroid group (SG) | Experimental | Drug: Methyprednisolon and low level laser theraphyFacial nerve injury will be created on the right facial nerve. Intraperitoneal methylprednisolone (1mg/kg/day) will be administered every day for 1 week postoperatively. |
| Laser+Steroid Group (LSG): | Experimental | Drug: Methyprednisolon and low level laser theraphyFacial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination. |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Thirty-five male Sprague-Dawley rats weighing 200-300 g will be included the study
Key exclusion criteria (1 listed)
- -Rats that are older than 6 months and are not healthy and have impaired facial motor functions will be excluded from the study.
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 |
|---|---|---|
| Methyprednisolon and low level laser theraphyAll rats will be anesthetized with ketamine hydrochloride at a dose of 50 mg/kg (i.p) (Ketalar ®, Eczacıbaşı Parke-Davis, İstanbul, Türkiye) and Xylazine HCl (Alfazyne ®, Alfasan International B.V. Woerden, Hollanda) at a dose of 10 mg/kg (intraperitoneal). A right postauricular incision will made under general anesthesia, and an external trunk of the facial nerve will be found. In the DCG and other experimental groups, the facial nerve was dissected, and it will be clamped with an average force of 150 g for about 1 minute. Afterward, the surgical area will be sutured in all rats in the DCG, L, S, and LSG groups. At the end of the 4 weeks of study, tissue samples will be taken from the facial nerve trunk in the control and experimental groups with a second surgical procedure preserved in formalin solution and sent for histopathological and biochemical examination. | Drug | Damaged Control Group (DCG):, Healthy Control Group (HCG), Laser Group (LG), Laser+Steroid Group (LSG):, Steroid group (SG) |
Primary outcome
Electromyographic Analysis
Time frame: 1 month
Measuring the amplitude and latency of the action potential occurring in the nerve with electromyography(On facial nerve)
1 secondary outcome
Biochemical Analysis
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
zeynep gümrükçü, Associate Professor study director
RTEU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methyprednisolon and low level laser theraphy in people with Nerve Injury and Laser Therapy, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 3 Jan 2024. 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 Turkey (Türkiye). 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic Analysis (time frame: 1 month). 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 3 Jan 2024.