Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation

NCT07351578 | Not Yet Recruiting

• 1 other identifier: CTO 5609
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Knee Arthroplasty; Transcranial Direct Current Stimulation; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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%)

  Pre-op Days -5 to +90 days

Secondary Outcomes (1)

• Treatment Acceptability

  Post-op 14 days

Other Outcomes (6)

• Pain Intensity

  Post-op day 1 to 90

• Knee-Specific Pain, Function, and Quality of Life

  Post-op day 1 to 90

• Postoperative Analgesic Medication and Opioid Use

  Post-op day 1 to 90

Study Arms (2)

Home-based tDCS

EXPERIMENTAL

receives active stimulation

Device: Active tDCS Stimulation

Sham tDCS

PLACEBO COMPARATOR

receives non-active stimulation

Device: Sham tDCS Stimulation

Interventions

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.

Home-based tDCS

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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Women's College Hospital: lead
• AFP Innovation Fund: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

Toronto Western Hospital (UHN)

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Karim Ladha, MD, FRCPC

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didem Bozak

CONTACT

416-323-6008; didem.bozak@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As noted above, only the company created the randomization will be aware of allocation assignment. The participant, Investigator, surgeon and outcomes assessors will be blinded to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc FRCPC

Model Details: This study will be a randomized, double-blinded, active-placebo controlled trial with two parallel arms.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CA (1)