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NCT05721261
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
NCT07416006
Intraoral surgical procedures such as sagittal split osteotomy, dental implant placement, and surgical extraction of third molars are widely performed interventions in oral and maxillofacial surgery. Although these operations are generally safe and predictable, they may cause direct or indirect injury to the inferior alveolar nerve, one of the main sensory nerves of the mandible responsible for the innervation of the lower teeth, alveolar bone, gingiva, lower lip, and chin. Damage to this nerve can occur due to mechanical trauma, compression, thermal injury, or stretching during surgery, as well as following facial or mandibular trauma. As a consequence, patients may experience various neurosensory disturbances such as anesthesia, hypoesthesia, paresthesia, or dysesthesia. These conditions often result in discomfort, reduced functional capacity, and psychological distress, affecting both esthetic and functional expectations after surgical recovery. Restoring normal nerve function in such cases remains a major clinical challenge in oral surgery and neuromodulation research. The inferior alveolar nerve follows a delicate anatomical path through the mandibular canal, where it is easily affected by surgical manipulations. Even minor trauma may lead to transient or permanent sensory dysfunction. The pathophysiology of such nerve injuries involves axonal degeneration, demyelination, and subsequent alterations in nerve conduction. Depending on the severity, nerve regeneration may occur spontaneously or may require therapeutic intervention. The degree of recovery depends on the extent of axonal disruption, the inflammatory response in the surrounding tissue, and the capacity of Schwann cells to facilitate remyelination. Traditional treatment approaches for inferior alveolar nerve injury include observation, pharmacological support, surgical decompression, or microsurgical repair. However, outcomes of these methods are often unpredictable, and recovery is slow. Therefore, noninvasive therapeutic modalities that can enhance neuronal healing and accelerate sensory recovery have become an area of increasing interest in modern dentistry and maxillofacial surgery. Among these, the use of laser biostimulation-also known as low-level laser therapy or photobiomodulation-has gained significant attention as a noninvasive, safe, and clinically applicable method to promote nerve regeneration. Laser biostimulation involves the application of light energy at specific wavelengths to biological tissues, leading to a cascade of photochemical and photophysical effects at the cellular level. When absorbed by mitochondrial chromophores, particularly cytochrome c oxidase, the photons increase cellular metabolism, enhance ATP synthesis, stimulate DNA and RNA synthesis, and promote cellular proliferation and differentiation. In neural tissues, this process can lead to activation of Schwann cells, enhancement of neurotrophic factor secretion, reduction of oxidative stress, and modulation of inflammatory mediators, thereby creating a favorable microenvironment for axonal regrowth. Consequently, photobiomodulation represents an advanced therapeutic approach to accelerate neural healing following both iatrogenic and traumatic nerve injuries. Two of the most commonly used laser types for biostimulation in clinical practice are diode and Nd:YAG lasers. Both operate in the near-infrared region of the electromagnetic spectrum but differ in wavelength, absorption characteristics, and depth of tissue penetration. The diode laser emits light typically between 800 and 1000 nanometers, with the 980-nanometer wavelength being one of the most widely used in dentistry. Its energy is well absorbed by melanin and hemoglobin, making it particularly effective in soft-tissue applications, wound healing, pain modulation, and superficial tissue regeneration. The Nd:YAG laser, operating at 1064 nanometers, has a longer wavelength that allows deeper tissue penetration. It is less absorbed by superficial pigments and more effective in reaching submucosal, muscular, and neural tissues. The differences in penetration depth and absorption profiles mean that while diode lasers are efficient for surface-level biostimulation, Nd:YAG lasers are more suited for stimulating deeper anatomical structures such as nerves and bone.
NCT07395388
This randomized controlled trial aims to evaluate the efficacy of intraoperative methylene blue (MB) spray in improving the identification and preservation of the recurrent laryngeal nerve (RLN) and parathyroid glands (PGs) during thyroidectomy. The study compares outcomes between patients receiving topical MB spray and those undergoing conventional visual dissection alone. Primary outcomes include the incidence of RLN injury and postoperative serum calcium levels.
NCT06867185
The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.
NCT05536609
Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.
NCT02359825
Current strategies for peripheral nerve repair are severely limited. Even with current techniques, it can take months for regenerating axons to reach denervated target tissues when injuries are proximally located. This inability to rapidly restore the loss of function after axonal injury continues to produce poor clinical outcomes. The investigators propose testing the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted axonal fusion technique to repair peripheral nerve injuries in humans.
NCT04144972
Chronic pain affects 1 in 4 US adults, and many cases are resistant to almost any treatment. Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but traditional approaches target only brain regions involved in one aspect of the pain experience and provide continuous 24/7 brain stimulation which may lose effect over time. By developing new technology that targets multiple, complimentary brain regions in an adaptive fashion, the investigators will test a new therapy for chronic pain that has potential for better, more enduring analgesia.
NCT04420689
Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery
NCT02718768
This is a multi-center prospective observational study that will capture detailed information about the treatment and long term outcomes of 250 patients with PNI resulting from upper extremity trauma. The study will focus on a young adult population to include individuals ages 18-65. Patients with PNI will be recruited during the hospitalization for initial treatment of the upper extremity injury. Additional patients may be identified during clinic visits for on-going treatment of upper extremity injuries as nerve injuries evolve or upon referral from outside physicians. However, all eligible nerve injuries must be treated within 6 months of the initial upper extremity trauma. Outcomes will be assessed at 3, 6, 12, 18 and 24 months following diagnosis of the nerve injury. All assessments will take place in the clinic and will include a patient interview and a brief exam to evaluate sensory and motor function.
NCT05160038
Virtual reality creates interactive, multimodal sensory stimuli that have demonstrated considerable success in reducing pain. Much research so far has focused on VR's ability to shift patients' attention away from pain; however, these methods provide only transient relief through means of distraction and therefore do not offer long-term analgesic remediation. An alternative and promising approach is to utilize VR as an embodied simulation technique, where virtual body illusions are employed as tools to improve body perception and produce potentially more enduring analgesia. Disturbances in body perception (i.e., alterations in the way the body is perceived) are increasingly acknowledged as a pertinent feature of chronic pain, and include aberrations in perceived shape, size, or color that differ from objective assessment. The degree of body perception distortion positively correlates with pain, and prior interventions have evinced that treatments aimed at reducing body perception distortions correspondingly ameliorate pain. Several recent experimental research studies have demonstrated the analgesic efficacy of body illusions in a range of pain conditions. Immersive VR multisensory feedback training signifies a promising new avenue for the potential treatment of chronic pain by supporting the design of targeted virtual environments to alter (distorted) body perceptions. Various illusions have been described to alter pain perception; however, they. Have not been directly compared to each other. The multimodal stimulus control of VR enables physical-to-virtual body transfer illusions, resulting in the feeling that the virtual body is one's own. These virtual body illusions can modulate body perception with ease and could therefore be used to alter the perceived properties of pain, consequently utilizing a virtual avatar to specifically shape interactive processing between central and peripheral mechanisms.
NCT01533337
The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.
NCT05337917
Case control study, investigating what hand function and sensory function do patients perform 3-10 years following digital nerve injury and repair. The aim is to investigate if hand function is more limited following digital nerve injury in the thumb, index- and little finger, compared to less unburdened sensory surfaces in the fingers. Secondary aim is to investigate the long term sensory function following digital nerve injury.
NCT04732936
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
NCT05302141
Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
NCT05242302
Ulnar nerve compressive injury due to cubital tunnel syndrome is very common. Because of the long distance to the target muscles in the hand, functional outcome in severe cases even with decompression surgery is often poor. Therefore, alternative treatment options are much needed. Recently, anterior interosseous nerve reverse end to side (RETS) transfer to the ulnar nerve above the wrist has gained popularity. However, whether a substantial portion of motor axons in the donor nerve are indeed capable of breaching the connective tissues in the ulnar nerve to reach the target muscles in the hand remains untested. To answer this crucial question, in this study the investigators plan to recruit 60 cubital tunnel syndrome patients with marked motor axonal loss who will undergo the RETS procedure. Motor unit number estimation will be done on the ulnar and anterior interosseous nerves at baseline and repeated at 3 and 6 months post operatively. Hand motor function and disability scores will also be tested at the same time points. Given the importance of this critical question and the potential utilities of distal nerve transfers, this should be a worthwhile effort.
NCT05283785
This study will evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve
NCT05198622
Intercostobrachial nerve (ICBN) is a cutaneous nerve that provides sensation to the lateral chest, upper medial arm and axilla. It arises from the second intercostal nerve and leave intercostal space at the level of midaxillary line. It then pierces the serratus anterior muscle and enters axilla. Intercostobrachial nerve is encountered during axillary lymph node dissection (ALND) while mobilizing axillary contents laterally off the chest wall and tends to tether axillary contents to the lateral chest wall. Many surgeons routinely sacrifice it as doing so makes mobilization easier and allow exposure of long thoracic neve. Currently there is no consensus on the usefulness of preserving intercostobrachial nerve. According to a 2020 systemic review and meta-analysis, prevalence of CPSP/ PPSP following breast cancer surgery ranged from 2% to 78% and pooled prevalence was found to be 35%. Higher prevalence was associated with ALND. Several risk factors have been identified which contribute to the development of PPSP. These include; Preexisting pain, preoperative opioid exposure, genetics, psychological factors such as anxiety, depression or catastrophizing, intensity of acute postoperative pain and nerve injury during surgery. As a result of nerve injury, damaged and non-damaged nerve fibers start generating action potential spontaneously. These are considered ectopic inputs as they do not arise from peripheral terminals. These inputs lead to the development of central sensitization, which is a state of exaggerated functional response of neurons involved in the pain pathway. This increased sensitization results due to increased membrane excitability, enhanced synaptic efficacy and decreased inhibition. The aim of the present trial is to investigate the effect of ICBN preservation on chronic/ persistent post surgical pain (CPSP/ PPSP). This will be achieved through a randomized control trial with CPSP/ PPSP as a primary outcome measure. Secondary outcome measures will include Health Related Quality of Life (HRQoL), operating time, lymph node yield, functional status of ipsilateral shoulder, post-operative complications and post-operative use of opioid analgesics.
NCT04115982
Digital nerve injuries are frequent in a FESUM center (Federation Européenne des Services d'Urgences Mains), and they need to be repaired in order to reduce the risk of hypoesthesia and to prevent painful neuroma. Several animal studies have shown that Cholecalciferol improves axonal nerve regeneration and myelination. No study has ever been done on human subjects to evaluate the nerve regeneration after Cholecalciferol supplementation. Our hypothesis is that Cholecalciferol supplementation could improve axonal nerve regeneration and myelination after traumatic digital nerve injuries treated by microsurgical sutures and reduce the risk of hypoesthesia and neuroma.
NCT04087577
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration. Conventional physical therapy includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues. However, the nerve regeneration takes several months in high-level median, ulnar or radial nerve injury. Prolonged median or ulnar nerves injury may interfere intrinsic muscular function, and radial nerve injury causes drop hand. Earlier nerve regeneration or motor training is essential for the patients to return to normal life and increase their quality of life
NCT04161261
This study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. It is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its duration. It is very unclear however if this applies to human cochlear implant patients, and what the optimal parameters are to selectively stimulate the hearing nerve in humans. The outcomes of this study will be used to more selectively program some patients with severe facial nerve cross stimulation and to inform the development of new types of implant stimulation.