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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for neuropathic pain management in people after spinal cord injury.

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 data supports the effectiveness of the treatment tACS for neuropathic pain after spinal cord injury?

While there is no direct evidence for tACS, similar treatments like transcranial direct current stimulation (tDCS) have shown mixed results in reducing neuropathic pain after spinal cord injury. Some studies suggest tDCS can be promising, especially with repeated sessions, but others found it ineffective, particularly in patients with long-standing injuries. ^{1 2 3 4 5}

Is tACS safe for humans?

The research articles provided do not contain specific safety data for tACS (transcranial alternating current stimulation) in humans. However, they discuss tDCS (transcranial direct current stimulation), a similar non-invasive brain stimulation technique, which is considered to have a lower risk of complications compared to invasive methods. ^{1 2 3 6 7}

How does tACS treatment for neuropathic pain after spinal cord injury differ from other treatments?

tACS (transcranial alternating current stimulation) is unique because it uses electrical currents applied to the scalp to modulate brain activity, which is different from traditional drug treatments. This non-invasive approach aims to relieve pain by targeting the brain's motor cortex, offering a potential alternative for those who do not respond well to medications. ^{1 2 3 5 8}

Research Team

Sheng Li, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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 am between 18 and 75 years old.

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

Exclusion Criteria

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

I have asthma or another lung condition.

Patient is not medically stable

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Longstanding neuropathic pain after spinal cord injury is refractory to transcranial direct current stimulation: a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of transcranial direct current stimulation for the management of neuropathic pain after spinal cord injury: a meta-analysis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

1-kHz high-frequency spinal cord stimulation alleviates chronic refractory pain after spinal cord injury: a case report. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation regulates phenotypic transformation of microglia to relieve neuropathic pain induced by spinal cord injury. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for spinal cord injury-associated neuropathic pain. [2021]

7. Scotland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a seven-year audit. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

Better Fields or Currents? A Head-to-Head Comparison of Transcranial Magnetic (rTMS) Versus Direct Current Stimulation (tDCS) for Neuropathic Pain. [2023]