Transcranial Direct Current Stimulation for Postoperative Pain

(KART Trial)

DB
Overseen ByDidem Bozak

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcranial direct current stimulation (tDCS) to determine its effectiveness in managing pain after knee replacement surgery. The goal is to reduce both immediate pain and the risk of developing long-term pain post-surgery. Participants will receive either active tDCS treatment or a placebo (inactive) version. The trial seeks individuals scheduled for knee replacement surgery due to advanced osteoarthritis who have access to a smartphone or tablet.

As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications or substances that affect brain activity, like antiepileptics, benzodiazepines, antidepressants, and antipsychotics, within the past 30 days.

What prior data suggests that this neuromodulation technique is safe for postoperative pain management?

Research has shown that transcranial direct current stimulation (tDCS) might be safe and helpful for managing post-surgical pain. In some studies, tDCS helped patients use less morphine and reduced their pain levels after operations. Specifically, one study found that patients using tDCS needed 46% less pain medication.

Another analysis demonstrated that tDCS reduced the amount of opioids (strong painkillers) required after surgery. While these findings are promising, more research is needed to fully determine the safety and effectiveness of tDCS for different types of pain. Overall, current evidence suggests that tDCS is generally well-tolerated, with no major safety concerns reported.12345

Why are researchers excited about this trial?

Transcranial Direct Current Stimulation (tDCS) is unique because it offers a non-invasive approach to managing postoperative pain, unlike traditional methods like opioids and NSAIDs, which involve medication. tDCS works by delivering a mild electrical current to the scalp, potentially altering brain activity to reduce pain perception. Researchers are excited about this treatment because it could offer pain relief without the side effects and addiction risks associated with standard pain medications. Additionally, the home-based application of tDCS makes it a convenient option for patients, potentially transforming how postoperative pain is managed.

What evidence suggests that tDCS is effective for postoperative pain?

Research has shown that transcranial direct current stimulation (tDCS) might help reduce pain in conditions like fibromyalgia and migraines. Studies have found that tDCS can decrease the need for opioid painkillers after surgery and lower pain levels. For instance, patients who received tDCS used less morphine and felt less pain after surgeries such as chest and spine operations. In this trial, participants will receive either active tDCS stimulation or a sham (non-active) tDCS treatment. These findings suggest that tDCS could also help manage pain after knee replacement surgery, possibly reducing the risk of long-term pain.12456

Who Is on the Research Team?

KL

Karim Ladha, MD, FRCPC

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

This trial is for individuals undergoing knee replacement surgery to ease pain from severe osteoarthritis. Participants should be willing to use a non-invasive brain stimulation technique at home before and after the surgery.

Inclusion Criteria

Access to a device running iOS Version 10.0 or above, or Android Version 5.0 or above that can connect to the internet
I am 18 years old or older.
I am scheduled for knee replacement surgery due to severe arthritis.
See 1 more

Exclusion Criteria

Pregnant
I have a history of brain surgery, CNS tumors, seizures, stroke, or brain implants.
Using other brain stimulation devices concurrently
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative tDCS Treatment

Participants self-administer tDCS sessions using a home-based device before surgery

5 days

Postoperative tDCS Treatment

Participants continue to self-administer tDCS sessions using a home-based device after surgery

90 days
Follow-up diary entries on postoperative days 14, 30, and 90

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • tDCS

Trial Overview

The study tests if using transcranial direct current stimulation (tDCS) at home can help manage acute pain better and prevent chronic pain after knee replacement surgery. Some will get real tDCS, others a sham (fake) treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Home-based tDCSExperimental Treatment1 Intervention
Group II: Sham tDCSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials
108
Recruited
43,700+

AFP Innovation Fund

Collaborator

Trials
9
Recruited
1,500+

University Health Network, Toronto

Collaborator

Trials
1,555
Recruited
526,000+

Citations

Effects of Transcranial Direct Current Stimulation on pain and ...

Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord injury and stroke ...

The effect of tDCS on postoperative opioid consumption ...

Our meta-analysis shows that compared to the sham group, tDCS can effectively reduce postoperative opioid drug consumption and alleviate postoperative pain in ...

Effect of Transcranial Direct Current Stimulation Combined ...

This study investigated the effect of tDCS vs. sham stimulation on postoperative morphine consumption and pain intensity after thoracotomy.

Transcranial Direct Current Stimulation (tDCS) in the ...

These preliminary findings indicate that tDCS may have the potential to decrease postoperative hydromorphone usage among lumbar spinal fusion patients. Future ...

Effect of Transcranial Direct Current Stimulation Combined ...

We hypothesized that tDCS will result in reduced postoperative morphine use (primary outcome) and lower postoperative pain intensity at rest, ...

Dose Dependent Effects of tDCS on Post-Operative Pain

In two independent preliminary pilot studies, the Investigators have shown that tDCS can reduce post-operative PCA use by as much as 46% while simultaneously ...