Recruiting

TMS & Yoga

Sponsor:

McMaster University

Code:

NCT06228573

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

Yoga

Study Details

Brief summary:

People with knee arthritis often experience constant pain, and current treatments aren't very effective. This can lead to limited movement and more health problems. Knee arthritis is a big part of healthcare costs in Canada, and its pain is a major reason people see doctors. The pain is linked to complex nervous system changes, making current treatments, like exercise, not very successful.

To address this, researchers suggest a new approach combining two things: a brain stimulation technique called Transcranial Direct Current Stimulation (tDCS) and yoga. TDCS helps with pain by changing how the brain works, and yoga, a safe practice, focuses on overall well-being. Together, the investigators aim to improve how the nervous system works from top to bottom.

The research project wants to change how the arthritis pain is being managed by focusing on how it works. The investigators plan to test this combo in a study comparing real tDCS plus yoga with fake tDCS plus yoga. The investigators will look not only at pain but also at other measures related to pain and how the nervous system works. This new mix could be a meaningful way to reduce pain for people with knee arthritis.

Conditions

Knee Osteoarthritis

Study ID

NCT06228573

Start date

Oct 20, 2024

Status verified date

Aug, 2026

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • community dwelling adults from Sherbrooke, Quebec, Hamilton and London, Ontario fulfilling the NICE criteria for KOA
  • ≥45 years of age
  • Diagnosis of Knee osteoarthritis OR
  • Having movement-related joint pain with either no morning knee stiffness or stiffness of 30 minutes or less AND
  • Experiencing an average pain intensity of ≥3 /10 in the past month

Exclusion Criteria:

  • Systemic inflammatory arthritis.
  • Any knee injection in the past 3 months.
  • Inability to independently get up and down from the floor.
  • Lower limb trauma or surgery within the last 6 months.
  • Current participation in another OA clinical trial.
  • Use of mobility aids.
  • Currently receiving care for KOA pain (e.g., physiotherapy).
  • Planned absences exceeding 1 week.
  • Contraindications to transcranial direct current stimulation (tDCS) such as neurological or neuropsychiatric conditions.
  • History of brain surgery or tumor.
  • Metallic implants.
  • Epilepsy or history of substance abuse or dependence.
  • Cochlear or ocular implant.
  • Presence of a pacemaker or cardiac defibrillator.
  • Eczema on the scalp.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS

Active tDCS Arm:

In Week 1, participants in the Active tDCS arm will undergo five in-person visits for the administration of active transcranial Direct Current Stimulation (tDCS). Subsequently, from Weeks 2 to 9, participants will receive weekly active tDCS sessions preceding the scheduled yoga sessions.

For the active tDCS sessions, a constant current stimulator will be employed to deliver direct current through a pair of surface sponge electrodes (5×7 cm) soaked in saline. Participants will undergo anodal stimulation targeting the primary motor cortex (M1) contralateral to the most painful site (C3 or C4 based on the electroencephalogram 10/20 system). The cathodal electrode will be positioned on the supraorbital area contralateral to the anode. During active tDCS, a constant anodal current of 2 mA will be administered for 20 minutes, a duration known to enhance cortical excitability and alleviate pain. T

sham comparator: Sham tDCS

Sham tDCS Arm:

tDCS: In Week 1, participants in the Sham tDCS arm will attend five in-person visits for the administration of sham transcranial Direct Current Stimulation (tDCS). From Weeks 2 to 9, participants will receive weekly sham tDCS sessions before the scheduled yoga sessions.

Constant current stimulator will be used to deliver direct current through a pair of surface sponge electrodes (5×7 cm) soaked in saline. Participants will undergo sham stimulation targeting the primary motor cortex (M1) contralateral to the most painful site (C3 or C4 based on the electroencephalogram 10/20 system).

During sham tDCS, the electrodes will be placed in the same montage as the active tDCS; however, current will only be applied for the initial and final 30 seconds of the 20-minute session. Consequently, participants will experience the sensation of current ramping up and down but will receive no current for the remaining stimulation period.

Interventions

Yoga

Yoga program: In weeks 2-9, participants will attend twice weekly 1-hour sessions of yoga led by a certified yoga instructor trained in the intervention by collaborator Pearson. Videos will be provided for completion of home sessions. The yoga program is based on the Pain Care Aware certification program.38 Details of the program as well as the training of instructors are provided in the appendices. Briefly, classes will consist of 3 parts: centring and warming up aimed at regulating physiology prior to beginning the yoga postures; yoga postures and guided relaxation.

Primary outcome measure

  • Percentage of complete follow up [ Time Frame: 9 weeks and 3 months ]

Central Contacts and Locations

Central contacts

Lisa Carlesso, PhD

2896805640carlesl@mcmaster.ca

Guillaume Leonard, PhD

(819) 780-2220Guillaume.Leonard2@USherbrooke.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S1C7

Contacts

Lisa Carlesso, PhD

289 426 2366carlesl@mcmaster.ca

University of Western Ontario

Recruiting

London, Ontario, Canada, N6A 3K7

Contacts

Siobhan Schabrun, PhD

sschabru@uwo.ca

Université de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1K 2R1

Contacts

Guillaume Léonard, PhD

guillaume.leonard2@usherbrooke.ca

More Information

Sponsor

McMaster University

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-08-28.