Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation (KART)

January 9, 2026 updated by: Karim Ladha, Women's College Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto Western Hospital (UHN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based tDCS
receives active stimulation
Device: Active tDCS Stimulation
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.
Placebo Comparator: Sham tDCS
receives non-active stimulation
Device: Sham tDCS Stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)
Pre-op Days -5 to +90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Acceptability
Time Frame: Post-op 14 days
tDCS Treatment Acceptability Questionnaire
Post-op 14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Post-op day 1 to 90
Assessed using Numeric Rating Scale (NRS)
Post-op day 1 to 90
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)
Post-op day 1 to 90
Postoperative Analgesic Medication and Opioid Use
Time Frame: Post-op day 1 to 90
Self-reported and converted to oral morphine equivalents
Post-op day 1 to 90
Quality of Life Assessment
Time Frame: Post-op day 1 to 90
Assessed using PROMIS-29 domain scores
Post-op day 1 to 90
Participant Blinding Success
Time Frame: Post-op day 1 to 90
Evaluated using the Bang Blinding Index (BBI)
Post-op day 1 to 90
Device Related Side Effects
Time Frame: Post-op day 1 to 90
Patient-Reported Side Effect Diary
Post-op day 1 to 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

University Health Network, Toronto
AFP Innovation Fund

Investigators

  • Principal Investigator: Karim Ladha, MD, FRCPC, Women's College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO 5609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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