Neurostimulation for Post-Stroke Pain

Overseen By Institutional RBFHR Recruitment Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Dementia, Uncontrolled depression, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new ear-based treatment can reduce chronic pain in individuals who have had a stroke. The study examines if 4 weeks of transcutaneous auricular neurostimulation (tAN), a technique that stimulates the ear, can alleviate arm pain. Participants will receive either 2 weeks of a sham (inactive) treatment followed by 2 weeks of real treatment, or 4 weeks of real treatment. The trial seeks individuals who experienced a stroke at least 6 months ago and continue to suffer from arm pain. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcutaneous auricular neurostimulation is safe for post-stroke pain?

Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe for people. One study found that this type of nerve stimulation, similar to the one used in this trial, is safe with only mild and short-term side effects, such as slight skin irritation or tingling. Other studies have demonstrated that tAN can be a helpful and safe addition to regular treatments, such as improving movement after a stroke. While more research is needed to confirm these findings, current evidence suggests that tAN is well-tolerated with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Auricular Neurostimulation (tAN) is unique because it offers a non-invasive approach to managing post-stroke pain. Unlike standard treatments that often rely on medications like opioids or antidepressants, tAN uses electrical stimulation applied to the ear to potentially modulate pain pathways. Researchers are excited about tAN because it targets the nervous system directly, potentially offering pain relief without the side effects associated with traditional drug therapies. Additionally, the at-home, self-administered nature of tAN provides convenience and empowers patients to manage their own treatment.

What evidence suggests that transcutaneous auricular neurostimulation is effective for post-stroke pain?

Research has shown that stimulating nerves around the ear, known as transcutaneous auricular neurostimulation (tAN), can help reduce long-term pain after a stroke. In this trial, participants will be randomized into different treatment arms to receive either sham or active tAN. Studies have found that using a device for this nerve stimulation can change brain signals, leading to less pain. This method offers a promising alternative to traditional pain treatments, like opioids, and provides potential benefits without major side effects. Additionally, early research suggests that tAN might also aid stroke recovery by improving movement. Overall, current evidence supports tAN as a promising option for managing pain after a stroke. ^{1 5 6 7 8}

Who Is on the Research Team?

Xiaolong Peng, Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for up to 24 people who have chronic pain in their upper extremity (like an arm) after experiencing a stroke. Specific details about who can join are not provided, but typically participants must meet certain health conditions.

Inclusion Criteria

I am between 18 and 80 years old.

I can understand and sign the consent form in English by myself.

I had a stroke more than 6 months ago.

Exclusion Criteria

Documented history of dementia

I have had a stroke caused by bleeding in the brain.

Documented history of uncontrolled depression or psychiatric disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 weeks of at-home transcutaneous auricular neurostimulation (tAN) for pain management

4 weeks

Self-administered at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Auricular Neurostimulation

Trial Overview The study is testing if transcutaneous auricular neurostimulation (tAN), which is stimulation of the ear, can help reduce chronic pain when used at home for four weeks by those who've had a stroke.

How Is the Trial Designed?

Group I: Four Weeks of Active Transcutaneous Auricular Neurostimulation Experimental Treatment 1 Intervention

Participants will be randomized to receive 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN), followed by 2 additional weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).

Group II: 2 Weeks Sham tAN followed by 2 Weeks Active tAN Experimental Treatment 1 Intervention

Participants will be randomized to receive 2 weeks of at-home, self-administered sham Transcutaneous Auricular Neurostimulation (tAN), followed by 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07144436

Study Details | NCT07144436 | Post-stroke Pain tAN-fMRI The purpose of this study is to explore whether 4 weeks of at-home transcutaneous auricular neurostimulation (tAN) can reduce chronic pain after a stroke.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12532841/

The protocol for a randomized, sham-controlled trial of ... Using a transcutaneous neurostimulation device for pain relief may be an effective alternative to opioid therapy [38, 39] and a useful method ...

3. withpower.com withpower.com/trial/ear-stimulation-for-post-stroke-pain-b2649

Ear Stimulation for Post-Stroke Pain · Info for Participants It has shown potential in reducing pain and promoting recovery in stroke patients, with no significant side effects reported.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05555485?rank=1

Understanding the Effects of Transcutaneous Auricular ... This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1676727/full

Clinical advances in transcutaneous auricular vagus nerve ... TaVNS has emerged as a promising non-invasive neuromodulation therapy for post-stroke disorders, demonstrating efficacy in addressing motor dysfunction, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7416299/

Effect and Safety of Transcutaneous Auricular Vagus Nerve ... This study revealed that taVNS appeared to be beneficial to the recovery of upper limb motor function in subacute ischemia stroke patients ...

7. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09171-4

The protocol for a randomized, sham-controlled trial of ... Using a transcutaneous neurostimulation device for pain relief may be an effective alternative to opioid therapy [38, 39] and a useful method ...