Peripheral Nerve Lesion / Nerve Injury
Conditions
Interventions
Brief electrical stimulation will be applied to the proximal nerve that was
repaired or decompressed. This will be applied for one hour, with a frequency
of 20 Hz, the same as in previous studies. I
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients eligible for enrollment are patients who are indicated for nerve surgery, eiter reconstructive or decompressive. This trial concerns patients in whom the nerve surgery is intended to improve symptoms of nerve degeneration. The following patient categories are open for inclusion: 1. brachial plexus nerve grafting procedures in adults 2. distal nerve transfers in adults 3. distal nerve grafting procedures in adults of the 3a. median nerve 3b. radial nerve 4. severe compression of the brachial plexus - neurogenic thoracic outlet syndrome (adults) 5. distal nerve transfer in adults after spinal cord injury In each of these categories a maximum of 20 patients can be included.
Exclusion criteria
Exclusion criteria: Patients not fit to agree to informed consent due to linguistic barriers for adequate communication. Patients who are not available for the designed follow-up schedule, for instance living abroad.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are 1) the occurrence of adverse effects 2) the feasibility of electrical stimulation, measured as the burden for the department and for the patient. The burden of the department will be measured as: direct costs of the electrical stimulation (stimulation device, electrodes, extra operative time, time used by neurophysiology department) and costs of the postoperative extensive evaluation. The burden for the patient will be outlined in detail below. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are the clinical effects of the electrical stimulation. It is not the aim of the current project to detect statistical differences in the stimulation and control group, but the goal is to make a reasonable estimation of effect size which can then be used for the design of a larger randomized trial in any of the patient categories. The following table summarizes the aimed outcome measures and the timing of follow-up. Patient category; Follow-up; Outcome measure 1. brachial plexus; 6/12/18/24/36 months; Biceps force (quantitative), EMG/Mune, DASH 2. distal nerve transfers; 6/12/18/24 months; Biceps force (quantitative), EMG/Mune, DASH 3a. nerve grafting median nerve; 6/12/18/24 months; Thenar reinneration, EMG/MUNE, sensibility of the hand (quantitative), DASH 3b. nerve grafting radial nerve; 6/12/18/24 months; Recovery of wrist and finger extension, DASH 4. nTOS; 6/12/18/24/36 months; Thenar and hypothenar reinnervation, EMG/MUNE, DASH 5. distale zenuwtransfers: 6/12/18/24 mnd; kracht vingerextensie; EMG/MUNE, DASH Physical examination: The examiner will be blinded for the assigned stimulation or no stimulation. The operative record will state that stimulation took place *according to study protocol*. Quantitative biceps force will be assessed with a hand-held manometer, or with dumbbells. Active external rotation will be assessed in degrees of active range of motion. Sensibility of the hand will be quantitatively assessed with Semmes-Weinstein filaments and 2 point discrimination. House-Brackmann score will be assessed testing active facial movements. Recovery of wrist and finger extension will be assessed with the MRC grade of volitional force. Questionnaires: DASH - Disability of Arm / Shoulder / Hand Ancillary investigation: Needle EMG (electromyography) - assesses semi-quantitatively the number of regenerated motor fibers MUNE is a electromyography technique to assess quantitatively the number of reg | — |
Countries
Netherlands
Outcome results
None listed