Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin)

Detailed Description
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Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy.

Official Title
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Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Device: transcranial dirrect current brain stimuation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment Exclusion Criteria: patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia, higher brain dysfunction, migraine headache, brain cancer or metastasis and those known to have epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active tDCS<br>tDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days | Device: transcranial dirrect current brain stimuation<br>* tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day),<br>|
| Sham Comparator: sham tDCS<br>tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds | Device: transcranial dirrect current brain stimuation<br>* tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day),<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the visual analogue scale | patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable | 0 (prestimulation), on the 5th day, 15th days and one month after the last session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS) | the patients will be asked to describe his pain by answering questions in yes or no; score ≥ 12 suggests neuropathic pain is likely to be involved and score < 12 suggests that neuropathic pain is unlikely to be involved | 0 (prestimulation),on the 5th day, 15th days and one month after the last session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy induced peripheral neuropathy, brain stimulation