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Could a headset ease pain after knee surgery?

NCT ID NCT07351578

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether a home-based brain stimulation device (tDCS) can help people recover better after total knee replacement. About 70 adults scheduled for knee surgery will use the device before and after their operation. The main goal is to see if the study is feasible, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcranial direct current stimulation (tDCS) device
What this could lead to
If it works, this could point toward a simple, non-drug way to manage pain after knee replacement and lower the risk of long-term pain.
What could go wrong
This is a small pilot study testing feasibility, not effectiveness. The approach is experimental, and results may not lead to a proven treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years of age or older. 2. American Society of Anesthesiologists (ASA) Physical Classification Status I-III. 3. Scheduled to undergo unilateral elective primary total knee arthroplasty for advanced osteoarthritis of the knee. 4. Access to a device running iOS Version 10.0 or above, or Android Version 5.0 or above that can connect to the internet. Exclusion Criteria: 1. History of brain surgery, central nervous system tumors, seizures (including epilepsy), stroke or intracranial implants (e.g plates, screws, deep brain stimulators) 2. Have vascular, traumatic, infectious, or metabolic lesions or diseases of the brain 3. Active diagnosis of a sleep disorder, defined as a documented diagnosis of any of the following conditions within the past 12 months, based on patient history or medical record review: * Insomnia disorder (e.g., difficulty initiating or maintaining sleep, early morning awakening) * Obstructive sleep apnea (OSA) * Central sleep apnea * Narcolepsy * Restless legs syndrome * REM sleep behavior disorder * Circadian rhythm sleep-wake disorders * Parasomnias (e.g., sleepwalking, night terrors) 4. Active diagnosis of alcohol use disorder, defined as meeting DSM-5 criteria or documented in the patient's medical record within the past 12 months. 5. Patients taking opioid medications with a daily Oral Morphine Equivalent (OME) of ≥ 80 mg 6. Current use of medications or substances known to alter cortical excitability or possess psychoactive properties (e.g., antiepileptics, benzodiazepines, antidepressants, antipsychotics, hallucinogens, dissociatives), as determined by review of the patient's medication list, chart review, and patient history. This includes prescribed medications and illicit substances used within the past 30 days. 7. Have metallic implants or objects in or on the head, including mouth (e.g. electrodes, stents, clips, pins, braces, shrapnel, jewellery (unremovable) 8. Use passive or active implanted medical devices (e.g., pacemakers, defibrillators, cochlear implants, natural implants or active body-worn medical devices (e.g., neural stimulation or medication infusion devices) 9. Have defects in the neurocranium (e.g., post-skull trepanation) 10. Have large vessel occlusions (e.g., complete blockage of the internal carotid artery or other conditions affecting brain perfusion 11. Have skin diseases of the scalp 12. Are using other brain stimulation devices concurrently 13. Are pregnant 14. Are unable to provide informed consent 15. Are unable to wear or tolerate the study device 16. Unable to speak or read English, or understand device operation instructions

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Toronto Western Hospital (UHN)

    Toronto, Ontario, M5G 2C4, Canada

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Other studies related to the condition(s) this trial covers.