Assessing Spinal Accessory Nerve Recovery After Post-operative Electrical Stimulation

NCT07074392 | Not Yet Recruiting

• 1 other identifier: 19054
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder weakness and pain are common after neck dissection surgery for head and neck cancer. This is often caused by injury to the spinal accessory nerve, which controls important shoulder muscles. Recovery can be slow and incomplete, affecting patients' ability to return to daily activities. This project will test whether a brief, low-dose electrical stimulation treatment can help the nerve heal faster and improve shoulder function. The treatment is applied during surgery and is safe, non-invasive, and quick to deliver. If successful, this approach could lead to better rehabilitation, less disability, and improved quality of life for patients undergoing cancer surgery. The project also supports the development of new medical technology and offers a pathway to expand the use of electrical stimulation in other nerve injuries.

Conditions

Head and Neck Cancer; Nerve Injury; Neck Dissection

Outcome Measures

Primary Outcomes (1)

• Constant Murley Score (CMS)

  Shoulder function will be assessed using the Constant-Murley Score (CMS), a validated composite measure of shoulder function. The CMS ranges from 0 to 100 points, where higher scores indicate better shoulder function. The score incorporates four components: pain (15 points), activities of daily living (20 points), range of motion (40 points), and strength (25 points). A score of 100 represents full, pain-free shoulder function with normal strength and range of motion, while a score of 0 reflects complete dysfunction.

  6 months post operative

Study Arms (2)

Standard of Care

NO INTERVENTION

Electrical stimulation

EXPERIMENTAL

Post-operative electrical stimulation of spinal accessory nerve post neck dissection.

Device: Electrical Stimulation

Interventions

Electrical Stimulation DEVICE

Custom stimulator will deliver a 1hour stimulation protocol post-operatively at 20 Hz, with biphasic pulses (100 µs duration, 0-2mA amplitude range).

Electrical stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing neck dissection

You may not qualify if:

• Previous neck dissection, previous implantable stimulator (i.e. pacemaker), previous spinal accessory nerve injury, pre-existing shoulder injury or weakness

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Related Publications (2)

• Costello MC, Errante EL, Smartz T, Ray WZ, Levi AD, Burks SS. Clinical applications of electrical stimulation for peripheral nerve injury: a systematic review. Front Neurosci. 2023 Aug 3;17:1162851. doi: 10.3389/fnins.2023.1162851. eCollection 2023.

  PMID: 37600003 RESULT

• Gane EM, Michaleff ZA, Cottrell MA, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. Prevalence, incidence, and risk factors for shoulder and neck dysfunction after neck dissection: A systematic review. Eur J Surg Oncol. 2017 Jul;43(7):1199-1218. doi: 10.1016/j.ejso.2016.10.026. Epub 2016 Nov 17.

  PMID: 27956321 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)