Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy

Overview

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)

Full Title of Study: “Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: January 2022

Detailed Description

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.

Interventions

  • Device: transcranial dirrect current brain stimuation
    • 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),

Arms, Groups and Cohorts

  • Active Comparator: active tDCS
    • 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
  • Sham Comparator: sham tDCS
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)
    • Time Frame: 0 (prestimulation),on the 5th day, 15th days and one month after the last session
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shereen Mamdouh, Associate professor – Assiut University
  • Overall Official(s)
    • Shereen M Kamal, Associate Professor, Principal Investigator, Assiut University
  • Overall Contact(s)
    • Shereen M Kamal, Associate professor, 01006279209, sheridouh79@yahoo.com

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