20 Participants Needed

TMS for Neuropathic Pain

JC
PS
DL
NM
DL
Overseen ByDennis Lambert
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
Must be taking: Chronic pain medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Chronic neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. It is highly prevalent, debilitating, and challenging to treat. Current available treatments have low efficacy, high side effect burden, and are prone to misuse and dependence. Emerging evidence suggests that the transition from acute to chronic neuropathic pain is associated with reorganization of central brain circuits involved in pain processing. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment that uses focused magnetic pulses to non-invasively modulate brain activity, a strategy that can potentially circumvent the adverse effects of available treatments for pain. RTMS is FDA-approved for the treatment of major depressive disorder, obsessive-compulsive disorder, and migraine, and has been shown to reduce pain scores when applied to the contralateral motor cortex (M1). However, available studies of rTMS for chronic neuropathic pain typically show variable and often short-lived benefits, and many aspects of optimal treatment remain unknown, including ideal rTMS stimulation parameters, duration of treatment, and relationship to the underlying pain etiology. Here the investigators propose to evaluate the efficacy of high frequency rTMS to M1, the region with most evidence of benefit in chronic neuropathic pain, and to use functional magnetic resonance imaging (fMRI) to identify alternative rTMS targets for participants that do not respond to stimulation at M1. The central aim is to evaluate the pain relieving efficacy of multi-session high-frequency M1 TMS for pain. In secondary exploratory analyses, the investigator propose to investigate patient characteristic that are predictive of responsive to M1 rTMS and identify viable alternative stimulation targets in non-responders to M1 rTMS.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. You need to be stable on your chronic pain medications for 4 weeks before the study and continue them throughout the study. Some medications will be reviewed by a TMS specialist to ensure they are safe to use with TMS.

What data supports the idea that TMS for Neuropathic Pain is an effective treatment?

The available research shows that repetitive transcranial magnetic stimulation (rTMS) can effectively relieve neuropathic pain. Studies indicate that high-frequency rTMS applied to specific brain areas can reduce pain. For example, a meta-analysis found that rTMS is more effective for pain that originates in the central nervous system compared to pain from peripheral nerves. Additionally, research suggests that rTMS may work by releasing natural pain-relieving chemicals in the brain. Overall, these findings support the idea that TMS is a promising treatment for neuropathic pain.12345

What safety data exists for TMS in treating neuropathic pain?

The safety data for TMS in treating neuropathic pain indicates that it is generally well-tolerated. In a randomized, multicenter, double-blind, crossover, sham-controlled trial, no serious adverse events were observed with daily high-frequency rTMS of the primary motor cortex. This suggests that TMS is a safe treatment option for neuropathic pain, although the analgesic effects are modest and transient.13678

Is the treatment High Frequency rTMS promising for neuropathic pain?

Yes, High Frequency rTMS is a promising treatment for neuropathic pain. It can relieve pain by stimulating the brain non-invasively, and studies show it can provide long-lasting pain relief. It is already approved for treating depression and has shown effectiveness in small studies for neuropathic pain.127910

Research Team

JC

Julian C Motzkin, MD/PhD

Principal Investigator

University of California, San Francisco

PS

Prasad Shirvalkar, MD/PHD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults aged 18-80 with chronic neuropathic pain lasting over 6 months due to nerve damage or disease. Participants must have a certain level of continuous pain, be able to tolerate the procedures, and give informed consent. They should be stable on their current pain medications and not pregnant, nursing, or have specific psychiatric conditions or contraindications for TMS.

Inclusion Criteria

I have been on the same pain medication for 4 weeks and can continue it during the study.
I have been on the same pain medication for 4 weeks and can continue during the study.
I have been diagnosed with chronic nerve pain.
See 12 more

Exclusion Criteria

I am not pregnant or nursing.
I am unable to commit to the full duration of the study.
I have not had major psychiatric disorders, thoughts of suicide, brain surgery, or electroconvulsive therapy.
See 4 more

Treatment Details

Interventions

  • High Frequency rTMS
  • Low Frequency rTMS
Trial OverviewThe study tests high frequency rTMS versus low frequency rTMS as treatments for chronic neuropathic pain. It aims to determine if stimulating the brain's motor cortex can reduce pain by modulating brain activity without the side effects common in other treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: High Frequency rTMSExperimental Treatment1 Intervention
High frequency 10 Hz stimulation of motor cortex (M1)
Group II: Low Frequency rTMSActive Control1 Intervention
Low frequency 1 Hz stimulation of motor cortex (M1)

High Frequency rTMS is already approved in United States for the following indications:

🇺🇸
Approved in United States as rTMS for:
  • Major Depressive Disorder
  • Obsessive-Compulsive Disorder
  • Migraine

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Findings from Research

High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) is effective in reducing neuropathic pain, with significant pain relief observed after just one and five treatment sessions, based on a meta-analysis of 25 studies involving 589 patients.
The analgesic effects of HF-rTMS can last for at least one month after five sessions, indicating its potential for long-term pain management in neuropathic pain patients.
High Frequency Repetitive Transcranial Magnetic Stimulation Therapy For Chronic Neuropathic Pain: A Meta-analysis.Jin, Y., Xing, G., Li, G., et al.[2018]
A study involving 66 patients with neuropathic pain showed that high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) targeting the specific pain region using navigation techniques provided significant pain relief, particularly for upper and lower limb pain.
The pain relief from navigated rTMS lasted for one week, indicating that navigation may enhance the efficacy of rTMS compared to traditional non-navigated methods, although it was less effective for facial or diffuse pain.
Analgesic effects of navigated motor cortex rTMS in patients with chronic neuropathic pain.Ayache, SS., Ahdab, R., Chalah, MA., et al.[2022]
Repetitive transcranial magnetic stimulation (rTMS) significantly reduces neuropathic pain, with a notable overall analgesic effect compared to sham treatment, as shown in a meta-analysis of 149 patients from 5 randomized controlled trials.
The greatest pain relief was observed in patients with trigeminal nerve pain (28.8% reduction), followed by post-stroke pain (16.7%) and spinal cord pain (14.7%), indicating that rTMS is more effective for centrally originated pain compared to peripheral sources.
rTMS for suppressing neuropathic pain: a meta-analysis.Leung, A., Donohue, M., Xu, R., et al.[2022]

References

High Frequency Repetitive Transcranial Magnetic Stimulation Therapy For Chronic Neuropathic Pain: A Meta-analysis. [2018]
Analgesic effects of navigated motor cortex rTMS in patients with chronic neuropathic pain. [2022]
rTMS for suppressing neuropathic pain: a meta-analysis. [2022]
Neurotransmitters behind pain relief with transcranial magnetic stimulation - positron emission tomography evidence for release of endogenous opioids. [2018]
The effect of repetitive transcranial magnetic stimulation on refractory neuropathic pain in spinal cord injury. [2021]
Daily repetitive transcranial magnetic stimulation of primary motor cortex for neuropathic pain: a randomized, multicenter, double-blind, crossover, sham-controlled trial. [2022]
Non-invasive Transcranial Magnetic Stimulation (TMS) of the Motor Cortex for Neuropathic Pain-At the Tipping Point? [2021]
Repetitive transcranial magnetic stimulation in neuropathic pain secondary to malignancy: a randomized clinical trial. [2022]
Neuropathic pain controlled for more than a year by monthly sessions of repetitive transcranial magnetic stimulation of the motor cortex. [2011]
[Transcranial magnetic stimulation and motor cortex stimulation in neuropathic pain]. [2021]