tACS for Neuropathic Pain After SCI

Overseen By Shengai Li, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Pain medications

Disqualifiers: Non-neuropathic pain, Pacemaker, Amputation, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 20

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment called transcranial alternating current stimulation (tACS) for managing neuropathic pain in individuals with spinal cord injuries. Participants will undergo different versions of tACS, where gentle electrical currents are applied to the scalp, to determine if it reduces pain. The trial seeks individuals who have experienced neuropathic pain for more than three months following a spinal cord injury and are stable on their current pain medications. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new pain management options.

Will I have to stop taking my current medications?

No, you can continue taking your current pain medications as long as they have been stable for at least two weeks before joining the trial.

What prior data suggests that transcranial alternating current stimulation (tACS) is safe for neuropathic pain management after spinal cord injury?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe. Studies on tACS and similar methods, such as transcranial direct current stimulation (tDCS), found no serious side effects. Most issues were minor, like slight skin irritation.

For the 10Hz and 20Hz tACS treatments, research involving various groups, including those with chronic pain, reported no serious problems. These findings suggest that the treatment is quite safe, as no major issues emerged in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial alternating current stimulation (tACS) for neuropathic pain after spinal cord injury because it offers a non-invasive approach to modulating brain activity. Unlike standard treatments, which often rely on medications like opioids or anticonvulsants that target pain pathways chemically, tACS uses weak electrical currents to entrain neuronal activity directly into specific frequency patterns, such as 10Hz or 20Hz. This method has the potential to provide pain relief without the side effects associated with medications, offering a novel approach that could revolutionize how we manage pain after spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for neuropathic pain after spinal cord injury?

Research has shown that transcranial alternating current stimulation (tACS) may help relieve pain. In this trial, participants will receive different tACS treatments. One arm will involve tACS at a frequency of 10Hz, which significantly reduced pain after a spinal cord injury in previous studies. For instance, one study on similar methods reported that patients experienced an average of 58% pain relief. Another arm will involve tACS at 20Hz, which has been effective in easing pain from other neurological conditions. Studies suggest that this frequency can change brain activity, potentially reducing pain. Overall, these findings suggest that tACS could be a promising non-invasive option for managing nerve-related pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Sheng Li, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-75 who have neuropathic pain following a traumatic spinal cord injury, amputation, or brain injury and have been stable on oral pain medications for at least two weeks. It's not suitable for those with pacemakers, metal implants, unstable medical conditions, non-neuropathic pain like inflammation from surgery wounds, arm amputations, psychiatric disorders currently adjusting their pain meds or with substance abuse issues.

Inclusion Criteria

I have nerve pain from a spinal cord injury, amputation, or brain injury.

I have been on a stable dose of oral pain medication for at least two weeks.

I have been experiencing pain for more than 3 months.

Exclusion Criteria

You do not show any movement in your arm muscles when tested with TMS.

Patient is not medically stable

You have a mental health condition before joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial alternating current stimulation (tACS) for neuropathic pain management, including sham, 10Hz, and 20Hz interventions

6-8 weeks

Multiple sessions with each session lasting 20-40 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tACS 10Hz
• tACS 20Hz
• tACS Sham

Trial Overview The study tests the effectiveness of transcranial alternating current stimulation (tACS) in managing neuropathic pain after spinal cord injuries. Participants will receive either a sham (fake) treatment or real tACS at different frequencies (10Hz or 20Hz) to see if there's an improvement in their pain levels.

How Is the Trial Designed?

Group I: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order Experimental Treatment 3 Interventions

1. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. 2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 3. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

Group II: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order Experimental Treatment 3 Interventions

1. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. 2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

Group III: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order Experimental Treatment 3 Interventions

1. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 2. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. 3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 138 patients with chronic neuropathic pain, 74.7% experienced over 50% pain reduction after trialing spinal cord stimulation (SCS), leading to permanent implantation for most of them.

One year after implantation, 84.4% of patients maintained significant pain relief, and many reported improved daily functioning and reduced reliance on opiate analgesics, highlighting SCS as an effective treatment option in a multidisciplinary pain management setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a seven-year audit. Sundaraj, SR., Johnstone, C., Noore, F., et al.[2005]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9106573/

Efficacy of transcutaneous electrical nerve stimulation in ... Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06029075

tACS for Neuropathic Pain Management After SCI tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7918133/

Efficacy and Safety of 10 kHz Spinal Cord Stimulation for ... At the last follow-up, average patient-reported percentage pain relief was 58% (N = 46), and 76% (35/46) achieved response to therapy. The ...

4. researchgate.net researchgate.net/publication/359163735_Efficacy_of_transcutaneous_electrical_nerve_stimulation_in_people_with_pain_after_spinal_cord_injury_a_meta-analysis

Efficacy of transcutaneous electrical nerve stimulation in ... Conclusions Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury, but due to the lack ...

5. link.springer.com link.springer.com/article/10.1007/s10072-025-08077-y

Efficacy of neuromodulation and rehabilitation approaches ... The therapeutic effect of rTMS in neuropathic pain is primarily attributed to its ability to modulate cortical excitability and neuroplasticity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12485468/

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 ...

7. nature.com nature.com/articles/s41393-022-00776-z

Efficacy of transcutaneous electrical nerve stimulation in ... Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1526590021001917

Modulating Brain Rhythms of Pain Using Transcranial ... We investigated the potential of tACS to modulate pain and pain-related autonomic activity in an experimental model of chronic pain in 29 healthy participants.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6123849/

Adverse events of tDCS and tACS: A review - PubMed Central No serious adverse effects have been reported in experiments using either tDCS or tACS. Persistent adverse effects of tDCS are mainly skin problems; for tACS, ...