Knee ArthroplastyKARTNCT07351578
Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation
A study testing Active tDCS Stimulation in people with Knee Arthroplasty and Transcranial Direct Current Stimulation, run by Women's College Hospital at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Transcranial Direct Current Stimulation, Pain, Postoperative
- What is being tested?
- Active tDCS Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Active tDCS Stimulation, Sham tDCS Stimulation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS StimulationDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based tDCS | Experimental | receives active stimulation Receives: Device: Active tDCS Stimulation |
| Sham tDCS | Placebo comparator | receives non-active stimulation Receives: Device: Sham tDCS Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcomes
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%)
Measured: Pre-op Days -5 to +90 days
Secondary outcomes (1)
Treatment Acceptability
tDCS Treatment Acceptability Questionnaire
Measured: Post-op 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a randomized, double-blinded, active-placebo controlled trial with two parallel arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund, University Health Network, Toronto
- Responsible party
- Principal investigator, Karim Ladha, Women's College Hospital
- Investigators
- Karim Ladha, MD, FRCPC, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351578
- Sponsor's protocol ID
- CTO 5609
- Acronym
- KART
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07351578
- Acronym / sponsor ID
- KART / CTO 5609
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- AFP Innovation Fund, University Health Network, Toronto
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a randomized, double-blinded, active-placebo controlled trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Home-based tDCS | Experimental | Device: Active tDCS Stimulationreceives active stimulation |
| Sham tDCS | Placebo comparator | Device: Sham tDCS Stimulationreceives non-active stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCS StimulationParticipants 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. | Device | Home-based tDCS |
| Sham tDCS StimulationParticipants 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. | Device | Sham tDCS |
Primary outcome
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%)
1 secondary outcome
Treatment Acceptability
Time frame: Post-op 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karim Ladha, MD, FRCPC principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS Stimulation in people with Knee Arthroplasty and Transcranial Direct Current Stimulation, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didem Bozak (416-323-6008, didem.bozak@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcomes (time frame: Pre-op Days -5 to +90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.