se of electrostimulation to correct aberrant facial reinnervation effects: a preliminary study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
The results of this clinical investigation showed that surface electrostimulation can be used to activate specific facial muscles safely and selectively without patient’s discomfort and/or unselective activation of other ipsi- and/or contralateral muscles. In particular, the results showed that the selective stimulation of the M. zygomaticus showing synkinetic M. zygomaticus - M. orbicularis oculi reinnervation could be achieved using a broad range of pulse widths (25-1000 ms) and an average amplitude = 6.2 mA that could further be decreased to 3.5 mA if the stimulation was delivered via rectangular rather than triangular waves. The most comfortable and effective results were observed with PWs between 50 and 250 ms, suggesting that this range should be preferred in future studies. The results of this clinical investigation showed that the electrode position on the face as well as the distance and configuration were critical in order to observe a specific response within the observed range.
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age = 18 years
- •- Diagnosed facial palsy with aberrant reinnervation of the M. zygomaticus and/or the M. orbicularis oculi
- •- Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation
- •- High motivation with realistic expectations regarding the participation in this clinical in-vestigation
- •- Signed and dated informed consent before the start of any clinical investigation specific assessment.
排除标准
- •- Lack of compliance with any inclusion criteria
- •- Pregnant or breast-feeding women
- •- conservative treatment (e.g. injection with botulinum toxin and/or wrinkle treatment by injection) during the last 3 month prior to inclusion in this clinical investigation
- •- physiotherapeutic treatment during the last 3 month prior to inclusion in this clinical investigation
- •- previous surgical treatment which, according to the opinion of the investigator, may influence the outcomes of this study and the effect of which cannot be separated from the effects of the electrostimulation.
- •- Other clinical diseases that might result in alteration of the outcomes of this clinical investigation (e.g. muscular and/or skin diseases, epilepsy)
- •- Use of an active medical implant
- •- Known allergies or intolerance to the material used for this clinical investigation
- •- Current participation in other drugs and/or medical device clinical investigations that can affect the results of the present clinical investigation
- •- Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation.