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Device

tDCS for Peripheral Neuropathy (NIBS4CIPN Trial)

N/A

Waitlist Available

Research Sponsored by Morgan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with painful chemotherapy-induced neuropathy

Be older than 18 years old

Must not have

Any neurological deficits (e.g., lower extremity weakness or bowel/bladder dysfunction, etc.)

History of frequent severe headaches

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes

Summary

This trial aims to test a new treatment called transcranial direct current stimulation (tDCS) for chemotherapy-induced nerve damage in cancer patients. tDCS is a safe and effective treatment that can

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While tDCS is generally considered safe, potential side effects may include mild tingling, itching or burning sensation at the electrode sites, fatigue, headache, nausea or discomfort during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I suffer from nerve pain due to chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no neurological deficits like weakness or bladder problems.

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I often have severe headaches.

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My heart disease is not stable.

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My blood pressure is not controlled by medication.

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I have seizures that are not controlled by medication.

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My cancer is at stage IV.

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I have a condition like MS or diabetes that affects my movement or sensation.

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I have not been hospitalized for mental health issues in the last 6 months.

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I have not tested positive for illegal drugs, except for marijuana.

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I have no non-removable metal or tattoos around my head, except for dental work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood oxygen level dependent (BOLD) response to cold heat stimuli

Blood oxygen level dependent (BOLD) response to painful heat stimuli

Blood oxygen level dependent (BOLD) response to sharp mechanical stimuli

+3 more

Secondary study objectives

Brief pain inventory short form score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Left motor cortex targeted anodal transcranial direct current stimulationExperimental Treatment1 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 stimulationPlacebo Group1 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.

0 / 11Eligibility criteria met