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Not yet recruitingNCT07074392SpARESUpdated Aug 19, 2025

Assessing Spinal Accessory Nerve Recovery After Post-operative Electrical Stimulation

An interventional study of Electrical Stimulation in Head and Neck Cancer, Nerve Injury and Neck Dissection, sponsored by McMaster University. Not yet recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by McMaster University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Sex
All
01

Study 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.

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Conditions studied

  • Head and Neck Cancer
  • Nerve Injury
  • Neck Dissection
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 38 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Undergoing neck dissection

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • No intervention
    Standard of Care
  • Experimental
    Electrical stimulation

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

    Device: Electrical Stimulation

Interventions

  • DeviceElectrical Stimulation

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

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What researchers measure

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.

    Time frame: 6 months post operative

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Study locations

1 site
  • St. Joseph's Healthcare
    Hamilton, Ontario, Canada
08

References and documents

Publications

  • 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. PubMed 37600003 ↗
  • 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. PubMed 27956321 ↗

Individual participant data

Plan to share: Yes — Demographics Patient outcomes (CMS scores, electromyography and patient reported outcomes)

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07074392
Lead sponsor
McMaster University
Responsible party
Sponsor
First posted
Jul 20, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Aug 19, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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