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NCT Number: NCT07351578

Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation

Total knee arthroplasty (TKA) is widely performed to reduce pain from advanced osteoarthritis, yet many patients experience severe postoperative pain and up to 25-44% develop chronic postsurgical pain (CPSP). Transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique, has shown promise in reducing pain and opioid use in early studies but has not been evaluated using comprehensive perioperative, home-based protocols. This study will test whether a home-based tDCS intervention delivered before and after TKA can improve acute pain management and reduce the development of CPSP.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital (UHN)

Toronto, Ontario, M5G 2C4, Canada

About this study

Participants will self-administer 15 tDCS sessions using a home-based device during the perioperative period. Feasibility and acceptability will be assessed through device-recorded adherence data, participant diaries completed during the intervention period, and follow-up diary entries on postoperative days 14, 30, and 90. Findings will be used to refine the protocol and inform the design of a future large-scale trial evaluating the efficacy of home-based tDCS for postoperative pain management following TKA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older.
  • American Society of Anesthesiologists (ASA) Physical Classification Status I-III.
  • Scheduled to undergo unilateral elective primary total knee arthroplasty for advanced osteoarthritis of the knee.
  • 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

  • History of brain surgery, central nervous system tumors, seizures (including epilepsy), stroke or intracranial implants (e.g plates, screws, deep brain stimulators)
  • Have vascular, traumatic, infectious, or metabolic lesions or diseases of the brain
  • 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)
  • 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.
  • Patients taking opioid medications with a daily Oral Morphine Equivalent (OME) of ≥ 80 mg
  • 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.
  • Have metallic implants or objects in or on the head, including mouth (e.g. electrodes, stents, clips, pins, braces, shrapnel, jewellery (unremovable)
  • 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)
  • Have defects in the neurocranium (e.g., post-skull trepanation)
  • Have large vessel occlusions (e.g., complete blockage of the internal carotid artery or other conditions affecting brain perfusion
  • Have skin diseases of the scalp
  • Are using other brain stimulation devices concurrently
  • Are pregnant
  • Are unable to provide informed consent
  • Are unable to wear or tolerate the study device
  • Unable to speak or read English, or understand device operation instructions

Treatment and study plan

Active tDCS Stimulation

Device

Participants will have electrodes positioned on their scalp at C3, C4 (primary motor cortices) and Oz (occipital cortex) according to the international 10-20 EEG system. They will receive active transcranial direct current stimulation (tDCS) to the primary motor cortex (M1) opposite the surgical site, with the Oz electrode serving as the return. Stimulation will be delivered at 2 mA for 20 minutes, including a 15-second ramp-up at the start and a 15-second ramp-down at the end. The PlatoWork 2.0 tDCS Neurostimulator headset will be used to administer the stimulation.

Sham tDCS Stimulation

Device

Participants will receive sham (inactive) transcranial direct current stimulation (tDCS) using the PlatoWork 2.0 tDCS Neurostimulator headset at home. The headset is identical to the active device but does not deliver electrical stimulation. This allows for blinding of participants to the intervention condition while maintaining the same study procedures and device usage as the active tDCS group.

Primary outcomes

  1. Feasibility outcomes

    Time frame: Pre-op Days -5 to +90 days

    Enrollment: number of patients enrolled per week (proceed if ≥1/wk; modify protocol if 0.5-1/wk; fail to proceed if <0.5/wk) Intervention Adherence: percent of randomized participants completing all stimulation sessions (proceed if >80%; modify protocol if 50-80%; fail to proceed if <50%) Data Completeness: percent of randomized participants completing the Numeric Rating Scale pain score at end of tDCS treatment; (proceed if >85%; modify protocol if 60-85%; fail to proceed if <60%)

Secondary outcomes

  1. Treatment Acceptability

    Time frame: Post-op 14 days

    tDCS Treatment Acceptability Questionnaire

Other outcomes

  1. Pain Intensity

    Time frame: Post-op day 1 to 90

    Assessed using Numeric Rating Scale (NRS)

  2. Knee-Specific Pain, Function, and Quality of Life

    Time frame: Post-op day 1 to 90

    Measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS)

  3. Postoperative Analgesic Medication and Opioid Use

    Time frame: Post-op day 1 to 90

    Self-reported and converted to oral morphine equivalents

  4. Quality of Life Assessment

    Time frame: Post-op day 1 to 90

    Assessed using PROMIS-29 domain scores

  5. Participant Blinding Success

    Time frame: Post-op day 1 to 90

    Evaluated using the Bang Blinding Index (BBI)

  6. Device Related Side Effects

    Time frame: Post-op day 1 to 90

    Patient-Reported Side Effect Diary

Study contacts

Contact information is provided by the study sponsor or research team.

Didem Bozak

CONTACT

[email protected]

416-323-6008

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • AFP Innovation Fund
  • University Health Network, Toronto

Registry information

Official study title

Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation: A Randomized Controlled Pilot Trial

Acronym: KART

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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