Accessory nerve palsy
Conditions
Interventions
Intervention Group (Pathleader Group)
Peripheral Magnetic Stimulation (Pathleader) add Standard Rehabilitation
Duration 16-19 days.
Frequency Once daily, 5 days per week (excluding weekends and public
Sponsors
Ataka Kota
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Preoperative Evaluation (1)Diagnosis of head and neck cancer, regardless of the primary site. (2)Adult patients aged 18 years or older at the time of providing informed consent. (3)Patients scheduled to undergo neck dissection (either modified radical neck dissection or selective neck dissection). (4)Patients who have received a thorough explanation of the study, understood its content, and provided written informed consent. At Postoperative Evaluation (1)Patients with abnormal CMAP (less than 50% compared to the contralateral side) as identified by postoperative electrophysiological examination. (2)Patients with stable systemic postoperative status. (3)Patients capable of participating in a 19-day inpatient rehabilitation program.
Exclusion criteria
Exclusion criteria: At Preoperative Evaluation (1) Patients scheduled for bilateral neck dissection. (2) Patients scheduled for radical neck dissection. (3) Patients with a Performance Status (PS) score of 3 or higher (those requiring assistance with activities of daily living). (4) Medical history: Patients with pre-existing shoulder disorders (e.g., rotator cuff tear, frozen shoulder, or history of fractures). (5) Patients with pre-operative shoulder contracture. (6) Patients with a history of central nervous system (CNS) diseases. (7) Patients with neuromuscular diseases. (8) Patients requiring continuous systemic steroid administration. (9) Contraindications for magnetic stimulation: Patients with implanted medical devices (e.g., cardiac pacemakers, defibrillators, cochlear implants, or other metallic implants). (10) Patients with a history of epilepsy. (11) Patients who are pregnant or may be pregnant. (12) Patients judged by the investigator to be ineligible for study participation. At Postoperative Evaluation (1) Patients whose accessory nerve function is either well-preserved or completely lost after neck dissection: Mild cases: CMAP amplitude preserved at >= 50% compared to the contralateral side. Complete paralysis: No CMAP amplitude detected. (2) Patients with postoperative complications (e.g., wound infection, hemorrhage, fistula formation, or wound dehiscence). (3) Patients with other comorbidities that interfere with the protocol treatment. (4) Patients requiring additional treatment (e.g., reoperation) based on postoperative pathological diagnosis. (5) Patients judged by the investigator to be ineligible for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in Compound Muscle Action Potential (CMAP) amplitude before and after the rehabilitation intervention during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional Outcome Measures a) Rate of change in shoulder abduction Range of Motion (ROM) b) Rate of change in shoulder abduction muscle strength (MMT / HHD) c) Change in the scapula-spine distance d) Barthel Index (BI) 2. Patient-Reported Outcome Measures a) Rate of change in the Visual Analogue Scale (VAS) b) Shoulder Pain and Disability Index (SPADI) 3. Safety Outcome Measures Adverse events, Vital signs, and Fatigue levels | — |
Contacts
Public ContactTatsuma Okazaki
Tohoku University Hospital
Outcome results
None listed