tDCS for Peripheral Neuropathy

(NIBS4CIPN Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called transcranial direct current stimulation (tDCS) for painful nerve damage caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). tDCS uses a gentle electric current to potentially improve how the brain handles pain and can be done at home. The study also examines how CIPN affects brain function and pain in Non-Hispanic Black and Non-Hispanic White patients, aiming to address health disparities. Individuals who completed chemotherapy or surgery for cancer at least three months ago and are experiencing painful CIPN may be eligible to participate. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve pain management for future patients.

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 prior data suggests that transcranial direct current stimulation (tDCS) is safe for treating chemotherapy-induced peripheral neuropathy?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. This technique has been used to alleviate various types of pain, such as fibromyalgia, migraines, and pain from spinal cord injuries. Studies have found that tDCS can safely reduce pain levels and assist with depression linked to chronic pain.

One study demonstrated that using a small electrical current for 20 minutes was safe and effective for individuals with nerve pain, with no serious side effects reported. Some individuals might experience mild sensations on the skin where the device is placed, such as tingling or itching, but these effects are usually minor and temporary.

Overall, research supports that tDCS is well-tolerated by most individuals, making it a promising option for managing pain, including pain caused by chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for peripheral neuropathy, which often involve medications like gabapentin or pregabalin to manage symptoms, transcranial direct current stimulation (tDCS) offers a non-invasive alternative. Researchers are excited about tDCS because it uses a gentle electrical current to stimulate the brain, potentially altering pain perception and reducing symptoms without the side effects common with medications. This method specifically targets the left motor cortex, which might directly influence how the brain processes pain signals, offering hope for a novel approach to managing peripheral neuropathy.

What evidence suggests that tDCS is effective for treating CIPN?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce pain and make it easier to manage. In earlier studies, five daily sessions of tDCS applied to the brain's movement control area provided quick pain relief for up to four weeks in individuals with diabetic nerve pain. This trial will evaluate the effectiveness of active tDCS versus a sham version for chemotherapy-induced peripheral neuropathy (CIPN), a painful nerve condition. tDCS alters how the brain processes pain. Since people from different racial groups can experience pain differently, tDCS might be more effective for some, particularly non-Hispanic Black patients, due to unique brain responses to pain. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

Able to read, write, and comprehend English

Non-Hispanic White or Non-Hispanic Black

Stable medication dosage over previous 4 weeks

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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) 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]

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]

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) 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]

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 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]

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]

Citations

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

Effects of Transcranial Direct Current Stimulation on pain and ... tDCS appears to decrease pain intensity and modulate thresholds for pressure and heat pain, as well as enhance tolerance to heat and cold.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0987705325000140

Evaluating the efficacy of transcranial direct current ... This review provides an overview of preclinical studies examining the effects of tDCS in rodent models of neuropathic pain.

3. nature.com nature.com/articles/s41598-020-75922-9

Non-invasive neuromodulation effects on painful diabetic ... They found that TENS therapy significantly improved generally neuropathic pain symptoms in the treatment of symptomatic DPN (ES = − 1.01, 95% CI ...

4. e-arm.org e-arm.org/journal/view.php?number=343

Randomized, Sham Controlled Trial of Transcranial Direct ... Five daily sessions of tDCS over the M1 can produce immediate pain relief, and relief 2- and 4-week in duration in patients with PDPN.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12255642/

Network Meta-analysis of Randomized Controlled Trials ... Data were collected on pain intensity of various adjunctive therapies for PDN, including transcutaneous electrical nerve stimulation (TENS), ...

6. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00244-2/fulltext

Efficacy and safety of transcranial direct current stimulation ... Safety outcomes were analyzed descriptively. For the safety population all patients who received any amount of stimulation were analyzed ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0987705324000029

Efficacy and safety of transcranial direct current stimulation ... tDCS is a safe intervention that relieves pain intensity, reduces depression, and reduces the impact of FM on life.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04306289

tDCS and Pain Associated With Diabetic Neuropathy The purpose of this study is to investigate the effects of anodal transcranial direct current stimulation (tDCS) on pain intensity associated with diabetic ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3895516/

Randomized, Sham Controlled Trial of Transcranial Direct ... A constant current with an intensity of 2 mA was used for a single 20-minute session. This protocol is safe and effective in patients with neuropathic pain [13] ...