tDCS for Peripheral Neuropathy

(NIBS4CIPN Trial)

Recruiting at 1 trial location

Overseen By Cynthia Renn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Morgan State University

Disqualifiers: Chronic pain, Neurological deficits, Diabetes, Substance abuse, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Over half of cancer patients receiving common chemotherapy treatments experience painful nerve damage called chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients are more likely to suffer from this condition and more often need to reduce their chemotherapy doses compared to Non-Hispanic White (NHW) patients. Currently, only one medication, duloxetine, is approved for treating CIPN, but it doesn't work for everyone. A new approach, transcranial direct current stimulation (tDCS), shows promise as a safe and effective treatment. tDCS can be done at home and reduces the need for hospital visits. Research indicates that tDCS can improve pain responses in the brain's pain control network. There are differences in pain sensitivity and brain activity related to pain between NHB and NHW individuals, which may influence the effectiveness of treatments. This research aims to conduct a study to: 1. Test if tDCS is a helpful treatment for painful CIPN. 2. Investigate how CIPN affects brain function in NHB and NHW patients. 3. Examine the role of inflammation in CIPN and its connection to pain severity and brain function. The investigators expect that NHB patients will benefit more from tDCS due to differences in their brain's pain response system. This project aims to address health disparities and improve outcomes for urban communities, particularly in Baltimore.

Will I have to stop taking my current medications?

The trial requires that your medication dosage has been stable for the past 4 weeks, so you may not need to stop taking your current medications if they have been stable.

What data supports the effectiveness of the treatment transcranial direct current stimulation (tDCS) for peripheral neuropathy?

Research shows that transcranial direct current stimulation (tDCS) can help reduce pain in conditions like diabetic neuropathy and multiple sclerosis, suggesting it might also be effective for peripheral neuropathy. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with mild side effects like itching and tingling being the most common. Studies have shown no serious adverse effects or irreversible injuries in over 33,200 sessions, even in potentially vulnerable groups like children and the elderly. ^{6 7 8 9 10}

How is the treatment tDCS unique for peripheral neuropathy?

Transcranial direct current stimulation (tDCS) is unique because it is a noninvasive brain stimulation technique that modifies brain activity to relieve pain, unlike traditional medications that target symptoms directly. It involves applying a small electrical current to specific brain areas, which can increase or decrease brain cell activity to help manage pain in conditions like peripheral neuropathy. ^{1 2 3 11 12}

Eligibility Criteria

This trial is for cancer patients with painful nerve damage from chemotherapy, known as CIPN. It's focused on understanding how this condition affects Non-Hispanic Black and White individuals differently and testing a home-based treatment called tDCS.

Inclusion Criteria

Stable medication dosage over previous 4 weeks

Able to read, write, and comprehend English

Non-Hispanic White or Non-Hispanic Black

Exclusion Criteria

Deficient folate levels (<7 nmol/ml serum)

Deficient vitamin B12 levels (<200 pg/mL serum)

I have no neurological deficits like weakness or bladder problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham transcranial direct current stimulation targeting the left motor cortex for 20 minutes once daily, Monday through Friday, for two consecutive weeks

2 weeks

10 sessions (at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain inventory and cortical thickness

6 weeks

1 visit (in-person)

Treatment Details

Interventions

• transcranial direct current stimulation

Trial Overview The study tests the effectiveness of transcranial direct current stimulation (tDCS) using Soterix REMOTE 1x1 miniCT in treating CIPN. It also examines brain function changes due to CIPN and explores inflammation's role in pain severity among different ethnic groups.

Participant Groups

Group I: Left motor cortex targeted anodal transcranial direct current stimulation Experimental Treatment 1 Intervention

Active left motor cortex targeted anodal transcranial direct current stimulation at 2 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks.

Group II: Left motor cortex targeted sham transcranial direct current stimulation Placebo Group 1 Intervention

Active left motor cortex targeted anodal transcranial direct current stimulation at 0 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks. The sham consists of a ramp up to 2 mA and immediate ramp down to 0 mA at the beginning of the 20 minute period and a ramp up to 2 mA and immediate ramp down to 0 mA at the end of the 20 minute period.

transcranial direct current stimulation is already approved in United States, European Union for the following indications:

Approved in United States as tDCS for:

• Investigational for Alzheimer's Disease and Frontotemporal dementia

Approved in European Union as tDCS for:

• Investigational for Alzheimer's Disease and other neurological conditions

Who Is Running the Clinical Trial?

Morgan State University

Lead Sponsor

Trials

7

Recruited

5,600+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

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]

Transcranial direct current stimulation (tDCS) is a noninvasive technique that can significantly alter brain functions and has been studied in 340 clinical articles for various conditions, including depression, pain syndromes, and neurodegenerative diseases.

The review provides a comprehensive overview of the clinical applications of tDCS, detailing factors such as study design, sample size, and stimulation parameters, which can help guide future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive database of published tDCS clinical trials (2005-2016). Lefaucheur, JP.[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]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., 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]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

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. France pubmed.ncbi.nlm.nih.gov

A comprehensive database of published tDCS clinical trials (2005-2016). [2022]

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

Effects of anodal transcranial direct current stimulation on chronic neuropathic pain in patients with multiple sclerosis. [2022]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [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. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

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

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]

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

Effects of simultaneous bilateral tDCS of the human motor cortex. [2018]

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

Effect of Transcranial Direct Current Stimulation over the Primary Motor Cortex on Cerebral Blood Flow: A Time Course Study Using Near-infrared Spectroscopy. [2017]