Electrical Stimulation for Diabetic Neuropathy Pain

Recruiting at 1 trial location

Overseen By Kimberly Puskus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Carbamazepine

Disqualifiers: Pregnancy, Severe depression, Neurological disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 1 week

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have pain resistant to common pain medications, which suggests you might continue your current meds.

What data supports the effectiveness of this treatment for diabetic neuropathy pain?

Research shows that transcranial direct current stimulation (tDCS), a part of this treatment, can help reduce pain in people with diabetic neuropathy. Studies have found that stimulating certain brain areas with tDCS can provide pain relief for patients with neuropathic pain, including those with diabetes. ^{1 2 3 4 5}

Is electrical stimulation for diabetic neuropathy pain safe for humans?

Transcranial direct current stimulation (tDCS) and other low-intensity electrical stimulations are generally considered safe for humans, with no serious adverse effects reported in thousands of sessions. Mild side effects like itching, tingling, and headaches are possible but usually temporary. ^{1 2 6 7 8}

How does the treatment of Active tDCS + Active TUS for diabetic neuropathy pain differ from other treatments?

This treatment is unique because it combines transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS), both non-invasive methods that target the brain to relieve pain. Unlike traditional pain medications, this approach directly stimulates specific brain areas to potentially reduce pain perception without the need for drugs. ^{1 2 3 4 9}

Research Team

Salim Hayek, MD

Principal Investigator

University Hospitals Cleveland Medical Center/ Case Western Reserve University

Eligibility Criteria

This trial is for people aged 40-80 with diabetic neuropathy pain in at least one foot, lasting over 6 months and resistant to common painkillers. Participants must have consistent pain levels and be able to give consent. Excluded are those with certain medical histories like severe head injuries, fainting spells, drug abuse, or metal brain implants.

Inclusion Criteria

You must be able to tell if you are feeling pain and report it.

My pain does not improve with common painkillers.

I have had diabetic foot pain for over 6 months, with pain most days and it averages at least a 4 out of 10.

Exclusion Criteria

I have a history of neurological disorders.

Subject is pregnant.

I have not taken carbamazepine in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive active or sham stimulation for 5 consecutive days, 20 minutes per day

1 week

5 visits (in-person)

Extended Treatment

Participants receive bi-weekly stimulation or sham for 2 weeks, 20 minutes per day

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

4 visits (in-person)

Treatment Details

Interventions

• Active tDCS + Active TUS
• Sham

Trial Overview The study tests the combination of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) against a sham treatment to see if they can reduce pain and improve function in patients with diabetic neuropathic pain.

Participant Groups

Group I: Active Comparator: Active tDCS + Active TUS Active Control 1 Intervention

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Group II: Sham Placebo Group 1 Intervention

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Highland Instruments, Inc.

Industry Sponsor

Trials

11

Recruited

650+

Findings from Research

Transcranial direct current stimulation (tDCS) applied over the primary motor cortex (M1) significantly reduced pain in patients with painful diabetic polyneuropathy (PDPN), showing immediate effects and sustained relief for up to 4 weeks after treatment.

In a study of 60 patients, those receiving tDCS over M1 experienced greater pain reduction compared to those receiving sham or dorsolateral prefrontal cortex (DLPFC) stimulation, indicating that targeting M1 may be an effective approach for managing pain in PDPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Kim, YJ., Ku, J., Kim, HJ., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) significantly reduced pain in patients with neuropathic pain due to type-2 diabetes, as shown in a study of 48 participants who received 12 sessions of treatment.

While the M1 stimulation group reported lower pain intensity immediately after treatment compared to the F3 group, both groups showed similar pain levels during follow-up, indicating that tDCS may be a beneficial but temporary add-on treatment for managing diabetic neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the separate and combined effects of anodal tDCS over the M1 and F3 regions on pain relief in patients with type-2 diabetes suffering from neuropathic pain. Alipour, A., Mohammadi, R.[2023]

A study involving 24 patients with chronic neuropathic pain will evaluate the effectiveness of self-administered transcranial direct current stimulation (tDCS) on pain relief, comparing its effects to previous treatments with repetitive transcranial magnetic stimulation (rTMS).

The trial aims to determine if tDCS can provide lasting pain relief and whether its efficacy differs between patients who previously responded to rTMS and those who did not, while ensuring safety through monitoring for adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a home-based transcranial direct current stimulation (tDCS) treatment device for chronic pain: study protocol for a randomised controlled trial. O'Neill, F., Sacco, P., Nurmikko, T.[2022]

In a case study involving a 24-year-old female patient undergoing 10 sessions of transcranial direct current stimulation (tDCS) for anorexia nervosa, hyperglycemia developed, leading to the onset of type I diabetes.

This case highlights a potential adverse effect of tDCS on glycemic control, suggesting that while tDCS is often studied for its benefits in other areas, its impact on blood sugar levels and diabetes risk requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Onset of Diabetes During Transcranial Direct Current Stimulation Treatment of Anorexia Nervosa - A Case Report. Mares, T., Ceresnakova, S., Albrecht, J., et al.[2020]

In a study involving 80 healthy participants, high-definition transcranial direct current stimulation (HD-tDCS) did not significantly reduce pain intensity from nerve growth factor-induced pain, indicating limited efficacy in acute pain relief.

However, HD-tDCS was effective in reducing the facilitation of temporal summation of pain in participants experiencing induced pain, suggesting that its benefits may be more pronounced in individuals with sensitized central pain mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study. Kold, S., Graven-Nielsen, T.[2023]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Deep repetitive transcranial magnetic stimulation (rTMS) using the H-coil significantly reduced pain levels in patients with diabetic neuropathy, as evidenced by a decrease in visual analogue scale (VAS) scores and RIII reflex area after treatment.

The study involved 25 patients, with 23 completing the trial, and showed that the pain relief effects lasted for about 3 weeks post-treatment, indicating that deep rTMS can effectively target deeper brain areas to modulate pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy. Onesti, E., Gabriele, M., Cambieri, C., et al.[2022]

References

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

Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of the separate and combined effects of anodal tDCS over the M1 and F3 regions on pain relief in patients with type-2 diabetes suffering from neuropathic pain. [2023]

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

Evaluation of a home-based transcranial direct current stimulation (tDCS) treatment device for chronic pain: study protocol for a randomised controlled trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Onset of Diabetes During Transcranial Direct Current Stimulation Treatment of Anorexia Nervosa - A Case Report. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

9. England pubmed.ncbi.nlm.nih.gov

H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy. [2022]